Declarations of the Comisión central de deontología

Transcription

Declarations
of the
Comisión
central de
deontología
2000
2015
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Declarations of the Comisión Central de Deontología
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Contents
The Ethics of Prescribing and Substituting Generic Medication ................................................................. 7
Limits to the Professional Functions of Doctors and pharmacists. ...........................................................13
The Ethics and Deontology of Medical Leave and End of Medical Leave Certificates
in Primary and Specialised Care and the Role of Medical Inspectors and its Control
and Supervision .........................................................................................................................................19
Declaration in Defence of Confidentiality and Medical Secrecy ...............................................................27
The Ethics and Deontology of the Second Medical Opinion .....................................................................33
The Computing Centralisation of Clinical History and Data. Ethical Principles in the
Protection of the Patient’s Privacy............................................................................................................41
The Stance of the Organización Médica Colegial de España regarding Collegiate
Members with Addictions or Mental Illnesses: Help Methods and Rehabilitation The
General Assembly of the Consejo General de Colegios Oficiales de Médicos (General
Council of Official Medical Associations), hosted on 3 December 2005, adopted the
agreement to approve the following declaration drawn up by the Comisión Central
de Deontología, Derecho Médico y Visado (Central Commission for Deontology,
Medical Rights and Endorsement):...........................................................................................................51
The General Assembly of the Consejo General de Colegios Oficiales de Médicos
(General Council of Official Medical Associations), hosted on 3 December 2005,
adopted the agreement to approve the following declaration drawn up by the
Comisión Central de Deontología, Derecho Médico y Visado (Central Commission
for Deontology, Medical Rights and Endorsement): ................................................................................52
The Involvement of Doctors with the Media in Cases of High Public Interest ..........................................59
The Ethics of the Professional Relationship of the Doctor with the Pharmaceutical
Industry and Health Companies ................................................................................................................63
Declaration on the Qualities of the Medical Certificate and its Differences to Medical
Notices and Reports. .................................................................................................................................69
Declaration on the Clinical History: Ethical and Deontological Aspects ...................................................77
The Ethics of the Professional Relationship of the Doctor with the Pharmaceutical
Industry and Health Companies ................................................................................................................89
Declaration of the Comisión Central de Deontología on the Conscientious Objection
of the Doctor .............................................................................................................................................95
“The Internal Borders in Professional Practise” ......................................................................................101
Hiring Doctors of Other Nationalities with an Imperfect Knowledge of Spanish....................................109
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Medical Ethics in Caring for the Mature Minor ......................................................................................115
Minimum Times for Medical Consultations ............................................................................................123
Medical Values in Research ....................................................................................................................129
Ethics in Palliative Sedation ....................................................................................................................133
Badajoz Agreement on the Teaching of Medical Ethics and Deontology ...............................................139
Organización Médica Colegial de España Statement on Medical Negligence........................................143
Statement from the Organización Médica Colegial de España on the Death of the
Footballer Daniel Jarque .........................................................................................................................145
Exaggerated Anxiety and Alarm are Being Created regarding Swine Flu...............................................147
The Ethics of Responsibility in Relation to Swine Flu ..............................................................................153
Conscientious Objection is a Right of all Citizens ....................................................................................157
Criteria and Recommendations for the Collegiate Recording of Conscientious
Objection .................................................................................................................................................161
Declaration of the Organización Médica Colegial on the Draft Bill on Sexual and
Reproductive Health (Abortion Law).......................................................................................................165
Declaration of the Organización Médica Colegial de España on Medical Action in the
Hunger Strike of Aminatu Haidar............................................................................................................169
Declaration on Conscientious Objection .................................................................................................171
Commitments and Demands of the Profession in Light of the Economic Crisis, the
Crisis of Values and the Governmental Crisis in the National Health System .........................................183
Informed Consent in Medical Practise ....................................................................................................195
Declaration on Healthcare for Undocumented Immigrants DECLARATION ON
HEALTHCARE FOR UNDOCUMENTED IMMIGRANTS ..............................................................................207
DECLARATION ON HEALTHCARE FOR UNDOCUMENTED IMMIGRANTS ................................................208
The Ethics of “Pharmacotherapeutic Guides” and the “Protocols for Therapeutic
Interchange” ...........................................................................................................................................213
Institutional Declaration on the Draft Bill on Abortion ...........................................................................219
Report on the Possible Contradictions that Royal Decree 16/2012, of 20 April, on
Urgent Measures to Guarantee the Sustainability of the Health System, May Have
with Ethics and Deontology ....................................................................................................................225
Declaration of the Comisión Central de Deontología of the Organización Médica
Colegial de España on the Medical Care of the Minor in Situations Involving the
Rejection of Treatment ...........................................................................................................................231
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Declaration of the Comisión Central de Deontología of the Organización Médica
Colegial de España on the “Restraint of Patients”..................................................................................245
The Figure of the Responsible Doctor .....................................................................................................251
Declaration of the Comisión Central de Deontología on Conscientious Objection .................................259
Declaration of the Organización Médica Colegial de España on Pharmaceutical Care .........................265
Proposals for a Quality Prescription .......................................................................................................271
Part II - ....................................................................................................................................................271
Ethics in the Practise of Acupuncture......................................................................................................313
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The Ethics of Prescribing
and Substituting Generic
Medication
Madrid, 27 March 2000
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The General Assembly of the Consejo General de Colegios Oficiales de Médicos (General
Council of Official Medical Associations), hosted on 25 March 2000, adopted the agreement
to approve the following declaration drawn up by the Comisión Central de Deontología,
Derecho Médico y Visado (Central Commission for Deontology, Medical Rights and
Endorsement):
THE ETHICS OF PRESCRIBING AND SUBSTITUTING GENERIC
MEDICATION
I. Introduction
1. The urgent issue of reducing health costs has been fiercely debated in the heart of
society and the medical and pharmaceutical professions in Spain in recent years.
Following the experiences of other developed countries, the generic prescription and
substitution of medication as practises that may contribute to substantially lightening
the financial load that comprise pharmaceutical spending has been proposed through
different petitions.
2. A generic prescription is given when the doctor completes the prescription of the
medication he recommends to his patient by writing its generic name. This leaves the
pharmacist with the option of dispensing the prescribed medication in the form of a
generic product among the diverse, generic options that exist or, in the event no such
stock exists and if the patient accepts it, as a registered brand product.
Generic substitution is given when the pharmacist dispenses a generic product (or,
possibly, a product by another registered brand) instead of the product by the brand
prescribed by the doctor.
3. Both generic dispensation and substitution imply some ethical requirements that are
derived from the basic mandate to do no harm. Assuming the correct indication of the
pharmacist, the use of generic medication is justified when equivalent to the
corresponding registered brand products. This requirement of equivalence must
include chemical equivalence (the generic product and the brand product contain the
same quantity of the same active therapeutic ingredient and the same dose);
bioequivalence (the generic product and the brand product have identical
bioavailability when the same dose is administered to the same individuals); and
therapeutic equivalence (the generic product and the brand product, when
administered in the same dose to the same individuals, produce the same therapeutic
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effect and provoke identical toxicity).
4. The health authorities are responsible for controlling the quality of medication,
independent of their generic or registered brand status. Authorisation to market
generic medication is just as demanding and it involves, in legal terms, identical
responsibilities and effects for pharmacists.
II. Generic prescription
5. As highlighted in the recent Declaration of the Comisión Central de Deontología
(Central Commission for Deontology) on the Freedom of Prescription, the doctor has
the duty to prescribe medication with rationality and good economic sense.
Prescribing the cheapest medication when its equivalent efficiency and safety are
guaranteed is a responsible and ethically required act as that is ordinarily the explicit
or implicit wishes of the patient or institutions, whether they be public or private, who
have to pay for it. However, prescribing an equivalent drug that is more expensive is
ethically reprehensible if there is no reasonable and convincing justification for such
an action. Said conduct is contrary to the guidelines regarding the rational use of
medication which, in addition to efficiency and safety, also demand cost effectiveness.
6. In this regard, the Comisión Central de Deontología supports the concept of the
prescription of low-cost medicine and health products, including generic prescription,
when the medicine or product’s efficiency and safety are certain. A doctor can, and
should, prescribe generic medication when he is clear it meets the strict ethical
requirements.
III. Generic substitution
7. The preceding recommendation in favour of generic prescription does not equate to a
blank cheque in favour of generic substitution. In ordinary conditions, the doctor
assumes final responsibility in the care of the patient, meaning the choice or selection
of medication must always be under the control of the doctor.
8. If the doctor has obtained the informed consent of the patient for the treatment plan,
this implies that said plan has been authorised by the patient. A substitution of
medication, even if it is only generic, may never occur without the consent of the
patient. Although the majority of patients view justified generic substitution as
reasonable due to the reduction in pharmaceutical cost, they have the right, after
receiving the pertinent information in understandable terms regarding the alternative
treatments from the pharmacist (article 10.5, General Health Law 14/1986) to freely
choose from the options presented to them (article 10.6 of the same law), which also
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implies the right, before making their decision, to have the substitution known and
authorised by the doctor.
9. If the pharmacist imposes generic substitution without the authorisation of the
doctor, it could create situations of high ethical and legal risk, in the event said
substitution was to result in undesired effects. In any case, said substitution may not
be carried out without the authorisation of the patient and the doctor, especially in
cases in which the adjustment of the treatment plan has been extremely laborious or
when the drugs have a very small therapeutic margin. In legal regulations, this fact is
recognised and lists of medication that may not be substituted for others available
have been published. Article 10.6 of the General Health Law cited previously highlights
that the doctor responsible for the case must be the person who offers the patient
treatment options.
10. Generic substitution must be the reason for cooperation, not conflict, between the
doctor and pharmacist. The pharmacist, despite his position as an expert in
medication, may not invade the doctor’s legitimate area of action and change the
treatment plan that the doctor has recommend to his patient: this would equate to
appropriating the power to prescribe, which is exclusive to the doctor. The pharmacist
should, when he has good reason to do so, communicate the pertinent differences to
the doctor so he may approve them and note them in his patient’s clinical history. The
doctor is obliged to accept and thank the reasonable and justified proposals of the
pharmacist.
11. The Comisión Central de Deontología is wholly convinced that genuine and productive
cooperation between doctors and pharmacists, both those in primary care and those
in hospitals, must be governed by two principles: the first, being traditional and in
force, taken from the Edict of Salerno, and which prevails in all developed societies, is
the separation of functions (doctors prescribe, pharmacists dispense), and the second
is inter-professional cooperation that enables the most to be made of the skills and
knowledge of doctors and pharmacists at the service of patients. Although
pharmacists are obliged by their profession to be experts on medication, they cannot
forget that doctors are experts on patients and ultimately responsible for healthcare.
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Limits to the Professional
Functions of Doctors and
pharmacists.
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Council of Official Medical Associations), hosted on 25 March 2000, adopted the agreement
Endorsement):
LIMITS TO THE PROFESSIONAL FUNCTIONS OF DOCTORS AND
PHARMACISTS.
Introduction
1. For some time, in the field of medicine, there has been growing concern provoked by
the expansion of the functions that pharmacists undertake in their pharmacies and the
fact that they do not appear to be far from constituting conduct that is out of place.
Changes of a diverse intensity and nature have contributed to this.
a. Firstly, social changes: the high consumption of medication funded by the Sistema
Nacional de Salud (National Health System), the decrease in the tolerance of the
small ailments and anxieties of life, and the ease of obtaining advice and medicine
from the pharmacist have resulted in an increase in the number of people who
attend pharmacies and have favoured the contact of pharmacists and their
assistants with clients.
b. Secondly, changes in the demography of the pharmaceutical profession: the
excess of graduates in pharmacology obliges not only individuals but also
professional corporations to tempt new outlets and functions that, logically, may
conflict with those possessed peacefully by other health professions.
c. Thirdly, changes induced by certain movements have arisen at the heart of the
pharmaceutical profession. Pharmacists have claimed, by virtue of their status as
experts in medication, a new prominence and autonomy in the monitoring,
control and modification of treatments prescribed by doctors. They wish to
assume, through what has come to be known as ‘pharmaceutical care’, new
functions and responsibilities in the programming of therapeutic objectives, the
control of interactions and adverse effects of medicines, and the reordering of
complex treatments. Some even estimate that they feel prepared to make fine
adjustments to drug therapy for the purpose of improving its economic
effectiveness and the quality of life of patients.
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d. Finally, some legislative changes that are referred to later.
2. The situation that is being created is worrying and, judging by appearances, some
pharmacists wish to delve deeper into an area reserved for doctors and break the
current paradigm of the strict professional separation of the functions of prescribing
and dispensing, a separation that must be preserved with the necessary adaptations.
Therefore, as it would be imprudent to waste the ability of the pharmacist regarding
his expert knowledge on the effects and interactions of medication, it would also be
extremely imprudent to assign the pharmacist the ability to modify the treatment
plans established by the doctor without the knowledge and acceptance of the doctor.
Undoubtedly, unauthorised modifications could constitute unqualified practise.
3. For the purpose of avoiding conflicts in relationships between pharmacists and
doctors, and maintaining the traditional cooperation between both professions, the
present Declaration is offered. In this Declaration, after referring to the ambiguity of
certain legal regulations regarding the matter, the ethical foundations that favour
open and constructive maintenance of the Salerno Principle, in terms of the necessary
professional separation of the acts of prescribing and dispensing, are highlighted.
Legal ambiguity: the generator of concern
4. The clarity of the legal guidelines that regulate the activities of the pharmacist,
contained in the Law from 29 July 1943 which, in chapter I defines the mission and
functions of the Faculty of Pharmacy and the professional value of its academic titles,
strongly contrasts with the silence, ambiguity or unclear nature of some subsequent
legal regulation such as the 25 April 1986 General Health Law, the 20 December 1990
Medicines Law and the 26 April 1997 Regulation of Pharmacy Services Law.
5. Specifically, in article 1 of this last law, a generic list of the functions assigned to
pharmacies is offered, and it includes some basic services that they must provide to
the population and constitutes a blank cheque for pharmacists to interfere in
functions that pertain to the genuine content of the medical profession. Support for
the expansionist policy that the pharmaceutical profession has been practising in
recent times can be found there. As such, pharmacies are attributed functions such as
the monitoring of patients’ pharmacological treatments or collaboration – it does not
state with whom – on the control of the customised use of medication for the purpose
of detecting and reporting adverse reactions that may occur, among other functions.
6. It is understood that the legal attribution of such imprecise functions to pharmacists is
an invitation to create conflict with doctors.
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On the one hand, it tends to place the pharmacy as the first link in healthcare by
inviting the individual to use the pharmacy as an initial instance of healthcare, which
requires that the person who is in charge of the pharmacy, or one of his assistants, is
competent in the diagnosis of the nature and significance of the complaint the client
describes. As such, the essential doctor-patient relationship is substituted by a new
pharmacist-patient relationship that is not free of risks.
On the other hand, it authorises the pharmacist to modify the treatment plan
prescribed by the doctor, despite the law not defining the extent and circumstances of
said prerogative, nor highlighting who is the person who is ultimately responsible for
the patient. As such, the peaceful doctor-pharmacist-patient relationship, which has
been in force up until now, evolves towards a triad that generates problems.
7. The 26 April 1997 Regulation of Pharmacy Services Law seems to facilitate the
interference of the pharmaceutical profession in the area of medical care, unless
measures are taken for the responsibilities of both professions and the field of their
mutual cooperation are perfectly defined.
Professional relationships between doctors and pharmacists
8. It is the opinion of this Commission that the two principles that have presided over
relationships between doctors and pharmacists in previous decades continue to hold
full validity: the principle of separating the two basic functions of the doctor
prescribing and the pharmacist dispensing, and the principle of cooperation between
pharmacists and doctors in order to optimise the use of medication in therapeutic and
economic terms.
9. The principle of separating the two basic functions of prescribing and dispensing is
supported by two basic and unchangeable reasons.
One is on a professional level: the necessary and irreplaceable professionalism and the
due competency in professional fields, which are clearly different. The doctor is not an
amateur pharmacist, nor is the pharmacist an amateur doctor.
The other is on an ethical level: the elimination of every risk of conflict of interest. The
decision to recommend a treatment may not be corrupted by the economic benefit
that may be derived by the person who recommends its. Practising doctors may not
be owners of pharmacies, nor may they prescribe medication when influenced by
financial considerations, nor may they sell health products or medication to their
patients. Pharmacists, with the exception of products of free dispensation, may not
sell, of their own initiative, medication that requires the presentation of a medical
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prescription to clients. The requirement of a medical prescription is the ethical and
legal proof that the pharmacist is a professional whose primary interest is to serve the
interests of the patient, not to obtain maximum economic benefits from his work.
10.
The principle of cooperation between pharmacists and doctors in order to optimise
the good use of medication derives its strength from the professional obligation to
best serve the interests of the patient and to not cause him harm.
This principles implies several obligations. Firstly, that of mutually communicating
errors that, during prescription or dispensation, may result in communication that
must always be friendly and considerate of professional reputation. Secondly, that of
offering and accepting the necessary information to prevent the appearance of
incompatibilities or undesired medical effects and to conveniently educate the patient
as to the best way to manage treatment. By mutual agreement, pharmacists and
doctors must develop methods of cooperation that improve patient care and involve
patient consent. The doctor must recognise the pharmacist as an expert in medication.
The pharmacist cannot forget that medication is applied not to abstract pathological
processes or statistical entities but to specific people with their individual traits.
11.
Recently, the Declaration on the Freedom of Prescription and the Declaration on
Prescribing and Substituting Generic Medication, both of which the Comisión Central
de Deontología (Central Commission for Deontology) is the author, have been
published. These declarations contain criteria that complement the present
Declaration. When preparing and debating these declarations, the Comisión Central de
Deontología was guided by the ethical criteria of protecting the rights and interests of
patients and of creating an atmosphere of cooperation between health professionals.
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The Ethics and Deontology
of Medical Leave and End of
Medical Leave Certificates
in Primary and Specialised
Care and the Role of Medical
Inspectors and its Control
and Supervision
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The Ethics and Deontology of Medical Leave and End of Medical
Leave Certificates in Primary and Specialised Care and the Role of
Medical Inspectors in its Control and Supervision
Introduction
The Spanish Constitution recognises, among the fundamental rights of Spaniards, the right to
work (article 35.1) in addition to the right to health protection (article 43.1), with it being the
responsibility of the public authorities to organise and safeguard public health through
preventive measures and the necessary services and benefits (article 43.2), by undertaking a
policy on welfare, treatment, and the rehabilitation and integration of the physically, sensory
and psychologically handicapped (article 49). For the right to health protection to be effective,
the General Health Law of 14 April 1986 was published.
Likewise, the Constitution recognises workers’ right to strike in the defence of their interests
(article 28.2) but it also recognises the right of workers and businesspeople to adopt collective
action (article 37.2) while ensuring the functioning of services that are essential to the
community. In other words, constitutional rights are not absolute: they have their limitations
when they conflict with other fundamental rights of the individual or society and they must
be safeguarded by the public authorities.
Social Security guarantees Spanish and foreign workers with residency and permission to
work in Spain the appropriate protection via health and economic services in situations of
common illness, non-work related accidents, occupational sickness, occupational accidents
and maternity.
Therefore, this is an area where health, social, occupational and other problems intermingle,
with the fraudulent use of the constitutional right to health protection not being uncommon,
whether it is to maintain a prolonged period of medical leave due to temporary inability or to
avoid, individually or collectively, obligations derived from having to ensure the functioning of
services that are essential to the community in situations of occupational conflict or strikes,
resorting to a situation of medical leave due to temporary inability in order to avoid the
minimum services outlined by the Administration, despite the fact these services may be
abusive.
These situations could result in connivance between the fraudsters and doctors who provide
them with medical leave certificates due to temporary inability or, perhaps, an abandonment
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of doctors to check the nature of the ailments that may justify temporary inability, which, in
any case, would damage the reputation of the doctor and would be contrary to the image of
the entire profession.
As such, the Comisión Central de Deontología (Central Commission for Deontology) has
deemed it convenient to draw up this Declaration to address medical professionals who
manage and process temporary inabilities.
General considerations
Temporary inability is understood as the situation in which the insured party is found, due to
illness (common or occupational) or accident, incapable of undertaking his work, in general
for a time superior to 72 hours, while he receives care from Social Security. Absence from the
job post for a period of time inferior to the aforementioned time is considered a minor
absence and economic payment during this period is regulated, generally, in the collective
agreements of each company, which may state the presentation of a doctor’s note for
absence is obligatory. In this case, the medical certificate may be interpreted as sufficient.
The situation of a worker in a state of temporary inability generates some health and other
economic assistance.
Given that absence due to temporary inability is requested by the worker who declares his
unavailability for work, the doctor is almost always obliged to facilitate this unless the
complaint alleged by the insured party were easily interpreted as a denial or demonstrably
suspicious fraud. The collective absence of a high number of workers would raise suspicions
of a fraudulent act but this situation may only be sensed by the doctor if an unusual number
of workers from the same company were to request medical leave in a short space of time,
although it would be difficult to detect this among the first few to request leave, given that
said workers could be assigned to different doctors depending on their places of residence
and, except for in small urban centres, the assessment of the action could pass unnoticed.
Legal framework
The legal framework for temporary inability is formed by a series of laws, royal decrees and
ministerial orders that are cited as appendices at the end of this document. The legal
framework does not constitute declaration material of the Comisión Central de Deontología,
unless it were to enter into clear confrontation with the principles of medical ethics and
deontology.
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Ethical framework
The ethical framework that constitutes the Code of Ethics and Medical Deontology (CEMD) of
the Organización Médica Colegial de España (Spanish Collegiate Medical Association).
Medical ethics and deontology
A) Of primary care doctors
1. Medical certificates of temporary inability due to common illness are, in general,
issued by primary care doctors of InSalud (the National Health Institute of Spain) or
autonomous communities that have assumed health transfers. However, Royal Decree
575/97 of 18 April and the Ministerial Order of 19 June 1997 do not specifically specify
that the issue of medical certificates corresponds uniquely and exclusively to said
physicians. Royal Decree 575/97, in article 1.1, highlights that medical leave will be
issued “by the public health service doctor who has performed the examination of the
affected worker,” while the Ministerial Order of 19 June 1997, which is explained
within the Royal Decree 575/97, highlights in article 2.1 that “the medical leave
certificate of temporary inability will be issued immediately after the medical
examination of the worker by the physician that performs it,” which leaves open the
possibility that said medical leave certificates may be issued by any doctor in the
public health service, which is equally applicable to the issue of end of medical leave
certificates.
2. Control of absences is also the responsibility of said doctors but they may also be
controlled by the doctors of Occupational Illness and Accident Insurance Companies
(Mutuas de Accidentes de Trabajo y Enfermedades Profesionales, or MATEP) and by
doctors of Companies Collaborating on the Management of the General Regime (selfinsuring companies), although these companies may make use of their own doctors or
Social Security doctors (Royal Decree 575/97, articles 3.2, 4.1 and 4.2).
3. Medical leave and end of medical leave certificates are official documents and the
doctor is ethically obliged to issue them with authenticity and veracity as expressed in
article 11.1 of the CEMD).
4. For the purpose of ensuring the authenticity and veracity of the medical leave or end
of medical leave certificate of the patient, but also to ensure the right all patients have
to medical care of a humane and scientific quality (CEMD, article 18), the doctor has
the duty, before issuing the corresponding medical leave certificate, to check, through
the physical examination and assessment of the patient, the complaint made in the
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request for temporary inability status despite knowing that many of the most
frequently alleged causes in requests for medical leave are difficult to confirm in the
examination performed in the health centre or consultant’s office given that, to give a
few examples, lumbago may or may not involve muscular contractions of the
paravertebral muscles, arthralgia does not always have to be accompanied by signs of
phlogosis or functional impotence, a headache or migraine do not always involve signs
of neurological focality, or a flu is not always accompanied by pathological lung
sounds.
If the diagnostic examination performed does not obtain sufficient information for a
correct professional decision and if deemed convenient for the study of the patient,
the doctor must request the complementary examinations or reports he deems
necessary, but during observation periods for common or occupational illness he
would be obliged to prescribe medical leave if the undertaking of the work could be
harmful to the worker.
5. In both the issuing of temporary inability certificates and in the prescription of the
treatment deemed appropriate, the doctor must have absolute freedom and
independence (article 20.1 of the CEMD) and he must not be pressured by the insured
party or health institutions or the health administration (articles 9.3 and 37.2 of the
CEMD) but, at the same time, the doctor must be conscious of his professional duties
to the community, knowing that he is a manager of independent resources and that
he is ethically obliged to achieve the optimum performance of the measures that
society puts at his disposition (article 6.1 of the CEMD), meaning he will always give
priority to the principle of equality over that of benefits in his professional practise.
This means that doctors who manage temporary inability are ethically obliged to avoid
prolonging medical leave and to proceed to issue the insured party with an end of
medical leave certificate once the cause that resulted in medical leave has
disappeared, temporary inexistence has been noted or in all other legally considered
cases. If a fraudulent act were to be suspected, they must, with discretion, make the
health inspection services aware of this – although this does not imply an infringement
on professional secrecy – by adopting the appropriate and necessary measures to
preserve the confidentiality of medical data (article 16 of the CEMD).
6. In order to favour the practise of what has been previously outlined, primary care
doctors have a help manual available for the management of temporary inability as
well as a standard practise guide for the duration of said inability processes, for the
purpose of detecting abnormal digressions in the duration of medical leave, notifying
the inspection control mechanisms when unjustified digressions are observed.
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B) Of specialised care doctors
7. Although the management of the majority of medical leave and end of medical leave
certificates is currently controlled by primary care doctors, especially in the nontransferred area of InSalud, said certificates may be, in applying the guidelines set out
in Royal Decree 575/97 of 18 April 1997 and in the Ministerial Order of 19 June 1997,
issued by specialised hospital and non-hospital care doctors. However, daily practise
has resulted in less specialised care doctors issuing these certificates lately. When they
do issue these certificates, these doctors are subject to the same ethical and
deontological imperatives as primary care doctors.
8. Regardless of the aforementioned, specialised care doctors are ethically obliged to
share, without reservation, their knowledge with primary care doctors for the benefit
of patients (article 31.3 of the CEMD), advising them on subjects that, due to their
position as specialists, they were consulted. The relationship between primary care
and specialised care doctors must be as fluid and extensive as demanded by patient
care, ensuring that the patient is not harmed by possible discrepancies in their
professional criteria or an unjustified delay in the issue of pertinent clinical reports.
9. If the specialised care doctor had not personally issued the patient’s medical leave
certificate but, through his specialised professional assessment, he were to conclude
that the patient should not be in a situation of temporary inability, he will discreetly
inform the primary care doctor who is directly managing the issue so he may take the
steps he deems appropriate, without interfering in the care the primary care doctor
was providing to the insured party (article 32.2 CEMD), with it being understood that
the primary care doctor is directly responsible for the patient and that, in this specific
case, the specialised doctor acts as a medical consultant.
C) Of medical inspectors
10. The responsibility for control mechanisms for medical leave and end of medical leave
at work falls upon medical inspectors of InSalud and the Instituto Nacional de
Seguridad Social (National Institute for Social Security, hereinafter INSS) in the event
of common and non-work related accidents and illnesses, and on MATEP doctors in
the event of occupational accidents and illnesses, although said doctors may also
control medical leave due to common illness in workers whose companies have
protected the risk with the corresponding insurance company, which may require
medical examinations to be performed by their corresponding medical services.
11. Medical inspectors must adjust their professional activities to the demands of the
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CEMD that apply to them (articles 2.1 and 41.1.) and acting as such will be
incompatible with medical care for the patient (article 43.3).
All medical acts – including those of INSS medical inspectors and those of doctors in
the service of MATEPs and self-insured companies – will be confidential in nature, will
respect the patient’s right to privacy and will be subject to professional secrecy (article
14 of the CEMD).
12. It is contrary to medical deontology and ethics to receive any commission or economic
incentives, apart from the remuneration that, in each case, the doctor has established
depending on the circumstances of the service provided and his professional
qualification (articles 40.2 and 40.4 of the CEMD).
As such the control of medical leave and end of medical leave situations may not be
motivated by the economic incentives that some insurance companies or self-insured
companies may offer doctors who were to reduce the duration of the insured party’s
medical leave, or were to grant a larger number of medical leave certificates for
economic purposes, in which the insured party, although continuing with his medical
leave, would stop receiving the economic subsidy corresponding to said situation.
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26
Declaration in Defence of
Confidentiality and Medical
Secrecy
27
Declaration in Defence of Confidentiality and Medical Secrecy
In light of the medical professional’s duty to maintain medical secrecy and the right of every
patient to the privacy and confidentiality of his information, and in view of how easy it is to
infringe on said rights, the platform in defence of confidentiality and medical secrecy
declares:
Privacy is an ethical and legal value protected by the Constitution and by current legislation in
our country and, as such, it must be demanded of and protected by professionals and users.
The supreme value of life and the defence of health are the reasons why, in the privacy of a
medical consultation, secrets are revealed that are not even told to immediate family
members. For this reason, confidentiality and medical secrecy are essential in the doctorpatient relationship.
Medical data pertains to each patient, who holds all rights over said data. The health
professional to whom the patient entrusts this data will act as a custodian, exercising rights as
an agent and person responsible for the patient.
Medical data is so relevant that if confidentiality fails, not only is privacy at risk, the exercising
of other fundamental rights is at risk, including the right to work, the right to education, and
the right to defend health and life. The right to confidentiality, which every patient has, is the
only guarantee in the defence of their privacy.
The patient has the right to be informed in a manner that is understandable: with regards to
the person responsible; the destination and use of his personal data; why his prior consent is
required for the gathering and use of data; and the right to access, rectify and cancel said
data. In short, the patient has autonomy and power of disposition over his personal data. As
established by the Constitutional Court, every patient has the fundamental right to the
protection of his personal data, which seeks to guarantee an element of control over this
data, its use and its destination.
Secrecy is a duty of the doctor and a right of the patient. Medical secrecy must be protected
in the handling of health information, whether in manual or computerised means, as
established in current legislation, which requires appropriate security measures that
28
guarantee the protection of patients’ personal data. Without these security measures, health
data must not be handled.
Only on limited occasions, and under the rule of law, the right to confidentiality may be
subordinate to other considerations. The violation of privacy, such as that of the home, may
only be justified by rights superior to others or the common good, as is the case with public
health. However, unlike the home and other properties, it must be considered that lost
privacy cannot be substituted.
In almost all scenarios, strict anonymity is identical to secrecy and anonymous data may fulfil
almost all administrative tasks. Only very limited personalised clinical information is relevant
to clinical management and none is relevant to the management of the information itself,
meaning none of these excuses may be used to justify the mass storage or centralisation of
personalised health information.
Information from consultations and electronic health history constitutes an element of
progress, however, in its use the risks to the confidentiality of data should be considered, due
to its ease of storage and the ease of hiding it, its infinite capacity to be copied and
transferred, its undetectable and negligible cost, and its unlimited processing and crossreferencing possibilities. There is no guarantee the protection of centralised medical data is
insurmountable, considering that the interest and value of so much information is high: one
leak, at a unique point, is enough for the damage to be catastrophic and irreparable. The mass
centralised storage of clinical information entails greater risks to secrecy and confidentiality
than distributed databases. Therefore, small shared technology solutions that avoid such a
high risk should take precedence where possible.
The concentration of data makes it desirable, which is why irrefutable reasons must exist to
justify the mass or centralised storage of information. The threat to confidentiality this
creates demands the total transparency of this kind of initiatives, which are sanctioned by the
consensus of independent groups (scientific, professional, legal, political, civic, economic and
commercial) depending on the pertinence and relevance of the specific data. During the stage
prior to the complete implementation of mass or centralised stores, the storage time,
guarantees and methods of irreversible destruction of the information and all its copies once
it has completed its purpose, must be determined.
Small, shared systems enable the protection of confidentiality, patient privacy and medical
secrecy, as established in the Code of Medical Deontology: medical information systems must
have the necessary security measures in place to prevent other people from accessing patient
29
data. Therefore, all files with clinical history and health data will be the responsibility of a
doctor and files with health data must not be connected to non-medical networks, such as
institutional networks. This is currently not observed.
Specific legislation must be established to protect the privacy of patients, to ensure no one is
discriminated against due to information related to health and to safeguard medical secrecy,
in specific development from articles 14 and 18 of the Constitution. It is vital that the health
of a person and the data related to him are never used against him or to discriminate against
him, regardless of whether its custodians are “legitimate.”
All citizens must defend and demand medical secrecy from the health professionals who
attend to them. Legislation is important but it must be the patients themselves who exercise
their right to be informed about what is done with their data, to decide who manages said
data and to defend medical secrecy.
Secrecy is also a prerogative of the doctor and a declaration of his right to conscientious
objection in tasks of an administrative, professional or any other kind of nature, parallel to
those that arise between him and his patient.
In Madrid on 23 June 2003
Consejo General de Colegios Oficiales de Médicos (CGCOM); Comisión de Libertades e
Informática (CLI); Federación de Asociaciones para la Defensa de la Sanidad Pública (FADSP);
Plataforma 10 minutos; Red Española de Atención Primaria (REAP); Sociedad Canaria de
Medicina Familiar y Comunitaria; Sociedad Catalana de Medicina Familiar y Comunitaria
(SCMFIC); Sociedad Española de Medicina General (SEMG)
30
31
32
The Ethics and Deontology
of the Second Medical
Opinion
33
agreement to approve the following declaration drawn up by the Comisión Central de
Deontología, Derecho Médico y Visado (Central Commission for Deontology, Medical Rights
and Endorsement):
THE ETHICS AND DEONTOLOGY OF THE SECOND MEDICAL
OPINION
I.
Introduction
1. In clinical practise in recent years, a notable increase in the frequency with which a
second medical opinion (SMO) – also known as a second consultation through which
the opinion of a second doctor regarding a problem, whether diagnostic or
therapeutic in nature, which previously presented itself to the other doctor, is
obtained – is requested has increased.
Resorting to SMO is not new, nor are criteria about how to do so lacking, given that
the matter was the subject of attention in the regulation of previous professional
etiquette and, more recently, in deontology codes. However, it must be recognised
that some ways of proposing and undertaking this are new, as is its usual use by
patients and their representatives, which is due to the efficiency and reliability of
telematic systems as well as the influence of certain social and cultural factors (greater
concern for health, abundant health information, democratisation of the clinical
relationship, emerging legislation regarding the practise of the SMO as a right of
citizens before national health systems).
2. Therefore, it is not strange that many developed countries, including Spain, are
considering not only the option of including the SMO in the growing list of patient
rights, as Law 16/2003 does in cohesion with the Sistema Nacional de Salud (National
Health System), but they have also proceeded to professionally and legally regulate its
practise in the disparate context of public and private medicine.
34
3. The SMO is a complex phenomenon. Reducing it to its most simplified terms, which
helps to situate the ethical approaches that follow, helps to highlight the following
features:
• It may be implemented by a doctor, the patient himself or third parties.
• Its usual aim is to clear up doubts about the established diagnosis or the
proposed treatment, whether looking for confirmation or its substitution by
more promising or justified alternatives.
• It is not unusual that this involves significant or emotional psychological
reactions that are capable of equally affecting those who participate in the
SMO (patients and their representatives, doctors, healthcare managers) and
the deterioration of their mutual relationships.
• It may take the form of a consultation involving the patient or it may be limited
to a direct or virtual check of clinical data and diagnostic material.
• It presents different methods in private medicine to public medicine, as they
are subject to diverse restrictions imposed by public health services or private
insurers.
4. The SMO presents different ethical components depending on the person who
initiates the process and the manner in which it is to be undertaken. As such the
principle methods of the SMO are defined: on the one hand, the method that uses an
ordinary, face-to-face doctor-patient relationship; and on the other hand, one that can
be done from afar using telematic resources. In the first case, a distinction must be
made among the SMO invoked by the doctor who originally attends the patient, the
SMO instigated by the patient himself and, finally, the SMO that may be initiated by
third parties.
5. The response a doctor gives to the request for opinion made by a colleague in an
informal manner regarding an unclear clinical situation, or regarding the difficulties of
interpreting diagnostic images, analytical data or problematic histopathological images
may not be considered a SMO. These consultations are made without referring to the
personal data of the patient, which are unnecessary, and they do not imply the
settlement of professional fees.
35
II.
Ethical and deontological considerations regarding the ordinary SMO
6. The SMO instigated by the doctor. The doctor who originally attends to the patient
must suggest a SMO when the best interests of the patient require it, especially in
cases of great complexity or uncertainty. It will be undertaken whenever the doctor
encounters problems that, in his own judgement, exceed his ability (article 19.1 of the
Code of Ethics and Medical Deontology, hereinafter CEMD). The SMO may never
appear to be a superfluous or abusive prescription, nor may it become an instrument
of defensive medicine.
Management of the SMO requires certain formalities of the doctor, including suitably
informing the patient, obtaining his free and informed consent to undertake it, the
choice of doctor who will participate in SMO made by the patient or, if applicable, the
free acceptance of the second consultant who is recommended to him, reference to
the second consultant in a document that contains the specific aspects regarding
which his qualified opinion is being requested, the making available of the relevant
clinical documentation to the colleague consulted facilitating (in compliance with
article 22.1 of the CEMD) the direct clinical meeting between the patient and the
second consultant.
7. The SMO instigated by the patient. Although this has become one of the globally
recognised patient rights, the SMO must be initiated due to serious reasons and
carried out and guided by channels of understanding and comprehension. It must not,
by virtue of its possible adverse effects (article 32.2 of the CEMD), be instigated by the
patient due to trivial reasons: genuine autonomy is based on rationality, not whims.
Therefore, it is advisable that the patient, before requesting a SMO, treats the matter
sincerely and amicably with the doctor who is attending to him. Although the patient
has the freedom to consult with the doctor of his choice (article 7 of the CEMD) he
must consider if he has sufficient reasons to seek a SMO behind the back of the doctor
who is attending to him.
8. No doctor has the right of ownership over his patients. As such, he may not feel
offended by the conduct of his patient when he seeks a SMO, nor may he reproach the
patient’s conduct as suspicious or oversensitive. The doctor must understand that it is
a very human and legitimate desire to make sure that some decisions on which many
important things depend are correct. It would be inappropriate, due to the fact a
36
patient were to reasonably desire a SMO, if his doctor were to terminate that
relationship. The doctor would only be authorised to do so, in accordance with article
32.3 of the CEMD, if the patient were to continue with the opinion expressed by the
second consultant, in light of which an irreconcilable difference would be presented.
9. Therefore, it is understood that the doctor may not ethically block the exercising of
the clinical freedom of his patient, nor may he impose difficulties in its practical
development. In contrast and for the purpose of preserving the relationship of trust,
which is necessary for an effective doctor-patient relationship, as stated in the
aforementioned article 7 of the CEMD, the doctor must facilitate its practise, conveying
the necessary documentation to the second consultant as soon as possible so he may
elaborate the opinion requested of him. The same conduct must be followed in public
medicine, by virtue of the rights of the patient regarding his clinical documentation
(article 18 of Law 41/2002 on Patient Autonomy and Rights and Obligations regarding
Clinical Information and Documentation).
10. Offering the patient the option of obtaining a SMO will become, in the near future, an
ordinary element of the information that is given to the patient regarding possible
treatment alternatives. As such, not only would patients be free of the aversion they
may feel in asking for a second opinion, their trust in their doctor would also increase.
11. The practise of the SMO will ordinarily reveal a substantial consistency in the
diagnostic and therapeutic conclusions of the original doctor and the second
consultant. Likewise, it will also reveal certain discrepancies that will be necessary to
agree on in the appropriate manner. In the event an agreement is not reached, the
doctors, who will have resolved their differences in compliance with the ethical
regulations of the college and polite disagreement, will present their opinions to the
patient or his representatives and they will respect, in accordance with the criteria
expressed in points 7, 8 and 9 of this document, the decision they make.
12. In no case may the care the patient must receive be suspended as a result of these
discrepancies. The original consultant must provide this care until another colleague
takes over responsibility for the patient.
13. The SMO instigated by third parties. It is not difficult to envisage the multitude of
problems that may arise, in a familial, occupational or social context, if the SMO is
37
instigated by the patient’s representatives, employers or other social agents. In
principle, any request for SMO that is not authorised by a patient who is of legal
capacity or, if he does not enjoy legal capacity, by his legal representative, must be
considered as contrary to ethics. In any case, it would constitute an undue invasion of
the patient’s privacy.
The doctor to whom a SMO is requested must verify, beyond all reasonable doubt, the
conformity of the request made by third parties with ethical regulations and rights.
Any exception to this criteria must be supported by justified, serious and defendable
reasons.
III.
Ethical criteria for the SMO managed by telematics
14. Developments in telematics have made distance consultations possible. This enables a
SMO to be requested and performed with consultants who practise in prestigious
national or foreign centres, at the same time as avoiding the inconveniences and costs
derived from displacements and stays outside the place of residence. Therefore, it is
not outlandish that the practise of SMO is one of the most immediate applications in
telemedicine.
15. It must be considered that the SMO managed by telematic means is affected by
problems inherent to telemedicine: some of a technical nature (quality control and
reliability of the subject issued, identification and verification of the participants,
authentication of messages), and others that are ethical in nature (obtainment of the
patient’s informed consent, confidentiality and the protection of the documentation
used, validation of the results). In order to analyse and resolve these problems, it is
advisable to bear in mind the documents of this Comisión Central de Deontología
(Central Commission for Deontology) regarding the matter: the Deontological
Regulations for the Doctor-Patient Relationship via the Internet, approved at the
session hosted on 25 and 26 July 2003, and the Declaration on the Ethical Guidelines
for the Informative Internet Pages of Medicine and Health in which Collegiate Doctors
Participate, approved at the session hosted on 28 and 29 November 2003.
16. With justified prudence, article 22.1 of the CEMD determines the ethical deficiency of
the practise of medical consultations performed exclusively using telematic
techniques. As such, the convenience that personal and immediate contact between
38
the consultant and patient, at any time, is understood. In the case of the SMO, it could
be a necessary and not only recommended substitute for contact between origin and
destination consultants. If said contact were not possible, the SMO would be seriously
weakened from a care point of view (it is reduced to the assessment of mere images
or data, not genuine patients) and an ethical perspective (risk of the clinical
relationship being treated as an object due to an absence of interpersonal dialogue).
IV.
Conclusions
a) The SMO must not be requested for capable patients – including mature minors –
unless they have requested or at least formally consented to this. With regards to
incapable patients, said incapacity must be documented in the SMO request along
with the name and legal title of the person making the request.
b) The information related to the SMO (including those related to informed consent and
medical data sent via the internet) must be saved in a clinical history file and remain
subject to the pertinent ethical and legal regulations.
c) The second consultant, when he receives the SMO request, must ensure, within the
scope of ethical respect for the freedom of the patient, request the patient or his
representative’s authorisation to contact the doctor who is responsible for the
patient’s care: non-consented care of a patient by more than one specialist may lead
to conflicts that do not favour either the patient or the doctors.
d) With regards to the payment of professional fees, the ethical and deontological
guidelines are clear: professional fees may not be accepted for acts that have still to
be carried out. Therefore, the practise of demanding advance payment for a
consultation, including any consultation that is performed virtually, is unacceptable.
Madrid, 15 December 2005
39
40
The Computing
Centralisation of Clinical
History and Data. Ethical
Principles in the Protection
of the Patient’s Privacy
41
and Endorsement):
THE COMPUTING CENTRALISATION OF CLINICAL HISTORY AND DATA.
ETHICAL PRINCIPLES IN THE PROTECTION OF THE PATIENT’S PRIVACY
I. Introduction
1. In recent years, due to the change in the way medicine is practised, problems have
arisen when attempting to balance the safe-keeping of personal medical data and
suitable access to this in order to facilitate patient care. The majority of actors in the
health sector agree on the need to computerise medicine; among others, the main
arguments used are the reduction in health errors and greater accessibility to the
information.
2. It is the duty of the doctor to maintain secrecy corresponding to the health of his
patients. It is the patient’s right that the institution for which the doctor works uses
every measure possible to safeguard the confidentiality of his health data.
3. The concentration of data makes it desirable, which is why very powerful reasons
must exist to justify the mass or centralised storage of information. The threat to
confidentiality that is created with this type of storage requires total transparency in
this type of initiatives, which are approved with the consensus of independent groups
(scientific, professional, legal, political, civic, economic and commercial) regarding the
pertinence and relevance of the precise information.
4. The storage time and the guarantees and irreversible destruction measures for the
information and all its copies once its purpose has been fulfilled, must also be
determined in the stage prior to the full implementation of mass or centralised stores.
Additionally, it should be determined what data will be stored and safeguarded for
investigation, epidemiological and other specified purposes.
42
II. Conflicts between accessing and safeguarding computerised clinical history
5. The vast majority of Spanish health centres share the same needs from a computing
point of view. From the centralisation of clinical files for their consultation from any
computer, to the use of the network for the transfer of medical documents, or the
management programme of a patient, all of these processes are shared by any health
centre. The use of a collection of applications that are common to the whole national
health system would permit the collection of public administrations to manage the
public health infrastructure in a much more efficient manner and apply the savings
gained from this standardisation to the implementation of better applications that
would enable improved patient care.
6. Computing systems ensure greater control over access to the registered clinical data
and greater transparency. However, they can also generate a greater risk of
unauthorised access and divulgation for purposes that differ to those for which the
data was initially gathered and stored. In institutionalised medicine, the high number
of people who, due to operational issues, have access to this type of information
makes the observance of absolute discretion impossible in practise. No effort must be
spared in security measures, even more so in this case as unauthorised access could
cause great harm (this harm would always be irreparable).
7. A computerised health card may save the full clinical history of a patient; therefore,
there is the advantage that only the professional who is treating the patient may
access the information and the data is not saved on an institutional computing
application. The health card may also be, without containing clinical data, the key to
allowing access to the information of the patient saved on a corporate system for care
information. A disadvantage is that it could be lost and, traditionally, it is the hospital
or health centre that is charged with looking after clinical histories; the patient must
always carry his card with him so it may be used in the event of an accident, attack,
etc. The health card system enables the citizen to maintain control over access.
8. The use of a unique computing programme across the diverse levels of healthcare,
whether it is for reading/writing on a health card or accessing the banks of health
data, facilitates patient care but it also makes the right to confidentiality more
complicated, which is why rigorous access control measures must be established
43
(Royal Decree 994/1999, of 11 June, chapter N). The Agencia para la Protección de
Datos (Data Protection Agency) is responsible for checking these control measures
exist and are fulfilled.
9. The proportion of the data and circumstances recorded by the doctor in a clinical
document that may be useful for other care or management sectors is very small. In
other words, only a small part of the clinical information of the patient may justifiably
leave the centre in which it is produced, and only when required, never systematically.
III. Guiding principles
General principles
10. In the computerised clinical history, the identity of the doctors and other professionals
who have participated in and accessed the clinical history at any time must be
recorded (Law 41/2002, articles 14.1, 14.3 and 16.7). It is important that they guard,
with diligence, their access keys, without revealing or putting them within the reach of
others, in order to protect clinical information, therefore avoiding both the access and
the viewing of this information by third parties. Likewise, every information output of
the medical data, whether in the form of a printout, in computing support, by email,
etc. must also be recorded. However, the responsibility of each and every one of the
professionals who directly or indirectly participates in the healthcare of patients may
not be substituted by any system with levels of access, passwords, encryption and
other measures necessary for the physical and technical protection of information
systems, given that computing programmes that discover passwords also exist.
11. Health and non-health professionals who, in the undertaking of their duties, have
contact with computerised clinical documentation are obliged to maintain the
professional secrecy of this information and its access keys; this requirement will be
maintained even if the professional link expires. Likewise, these individuals are
responsible for guarding and protecting the confidentiality of said information. Access
keys must be changed periodically and for each authorised person for the purpose of
protecting access to the data.
12. Selective access to the data, duly separating the data relative to the identification of
individuals, medical data, administrative data, social data and genetic data is basic. No
44
one, except the health staff member responsible for the care of a patient, will be able
to access the full details of the patient’s clinical history, given that the patient has
exclusively given permission to that person. This is the great advantage of a
computerised health card.
13. Article 61 of the General Health Law only authorises access to clinical history to “the
physicians who are directly involved in the diagnostic and treatment of the sick
person, or for medical examination or scientific purposes.” All others (family members
of the sick person who do not have his consent, doctors or health staff who are not
directly involved in treatment or diagnostic, health and non-health staff who do not
undertake examinations or scientific tasks, insurance companies with the exception of
their medical experts and only them) are not “authorised personnel” and,
consequently, if they access this data without the consent of its owner, this may be
viewed as a criminal act with severe punishments, provided for in article 197 of the
Criminal Code. The crime is committed by the person who accesses or overpowers,
uses or modifies the personal or family data of another that is recorded in
computerised, electronic or telematic files or supports, or on any other kind of public
or private file or record.
14. Computerised clinical history may be organised in three storage levels: 1) basic data
that the patient knows may be used by any professional who participates in his care,
although it may not be his usual doctor or nurse (the head doctor will negotiate with
the patient what this data must include), 2) private data to which access is only
allowed with the express permission of the patient, and 3) reserved data to which the
patient does not have access as it gathers the subjective observations that
professionals consider necessary to withhold for care reasons, or data related to third
parties.
15. The doctor who practises his profession privately is responsible for the patient
information that is recorded in the computing applications he uses. In public practise,
the doctor will also be responsible for the computing files of patients of which the
person responsible for the health centre has no knowledge.
16. The doctor will be able to cooperate on audits (epidemiologic, economic or
managerial) on the express condition that the information used in them does not
45
enable the direct or indirect identification of any patient in particular (CEMD, article
17.5).
17. Staff responsible for computing systems and communication networks must take
special care to safeguard usernames and passwords that provide access to systems
with administrator privileges. The transmission of medical data through
telecommunication networks must be done through the encoding of said data or by
using a system that guarantees the information cannot be understood or manipulated
by third parties. Through the knowledge and monitoring of weaknesses and faults
detected in systems, administrators can improve the security of equipment they are in
charge of.
Specific deontological principles
18. In the search for the longed-for balance that would render it possible to make the
most of the advantages of the responsible introduction of computing in medicine,
minimising the risks to the security of personal data, some deontological principles
gather the most convenient requirements for the protection of computerised health
data:
•
The principle of moderation (pertinence)
o In accordance with this principle, health professionals must limited
themselves to collecting and recording what is strictly necessary to
ensure quality medical care. Regardless of how difficult it may be to
definitively eliminate data entered on some kinds of computing
systems that enable the recovery of apparently deleted files, it is
advisable not to record, unless essential, details that, if revealed,
could endanger data that is highly sensitive in terms of our patients’
privacy.
•
The principle of transparency
o It is advisable to act correctly while also ensuring that the doctor is
seen to be acting in this manner, such that the application of new
technology is not considered another instrument that is exclusively
aimed at improving efficiency, but that it actually serves to promote
46
human values such as confidentiality. In this regard, the best thing
is for the patient to understand what kind of information regarding
his person is gathered as well as who may access this information,
and under what conditions.
•
The principle of responsibility
o This principle is closely linked to the Hippocratic motto primum non
nocere. On the one hand, this implies that professionals must be
careful and responsible in the handling of data, given the
consequences small errors or oversights may cause for patients. On
the other hand, it reminds doctors that team work must not be
used as an excuse to blur the lines of responsibility.
•
The principle of universal protection
o This refers to the fact that security measures to protect health data
must always be applied in all centres and for all users (also for
professionals when they are patients, for example).
IV. Conclusions
19. It is up to autonomous and central governments to regulate conflicts between local
computing programmes and those of autonomous health services, bearing in mind
that they must use all measures possible to respect patients’ right to confidentiality
(CEMD, article 17.a and Organic Law 15/1999 of 13 December). It is advisable to
establish functional units of clinical documentation dedicated to the supervision of
security measures. It should not be forgotten that the doctor-patient relationship
requires safeguarding and some values (respect for the autonomy of patients, the
existence of an implicit agreement in the clinical relationship, social trust in the
discretion of the medical profession, due loyalty to the patient) must always be
safeguarded if the health system is to function.
20. Consumer and user associations, in addition to associations for sick people, must be
consulted by those responsible for health in each autonomous region in order to
include the various levels of security that said associations request in computing
applications. This is a way in which patients participate in decisions and are informed
47
of the risks to confidentiality that centralised databases involve; they have the right to
be informed as to what is done with their information and to decide who manages it.
21. Only those who are treating the patient or those who encode the patient’s data may
have full access to the clinical history, given that the care professionals at the centre
where diagnostic, treatment and patient care is performed have access to the clinical
history of the patient as an essential instrument for appropriate care. Both primary
care and specialised care professionals must be informed, in a transparent manner, by
the head of the health centre as to how the computing system that is used functions
and who may have access to it.
22. The central services of an autonomous health service that, for example, require
epidemiological and administrative data, etc. to make decisions may only have
selective access, such that clinical and administrative data will be dissociated (CEMD
article 17.2 and Law 41/2002 article 16) and they are also bound to the duty of
secrecy. Therefore, they must have access profiles and convenient division, for both
the users of the computing information and the information needs.
23. Databases of health information extracted from clinical histories will be the
responsibility of a doctor and may not be connected to a non-medical computing
network (CEMD article 17.3 and 17.4). The mechanisms that enable the recording of
data will be under his direct control and the deactivation of these will not be
permitted in any case.
24. Currently, the centralisation of clinical history data must be advised against until
security systems and conditions improve.
25. Systems must undergo an independent audit that enables the certification of its
characteristics and security as well as the determination as to what information and
data pertain to each of the different levels. Likewise, an independent and specific
committee will continually monitor the need, pertinence, and relevance and
conservation time during the period that is reasonably useful in achieving the purpose
that justified its capture and computerised treatment. If applicable, due to the interest
of public health, medical science, or historical or statistical purposes, this data must be
anonymous to ensure the privacy of the patient.
48
26. Public interests such as (occasionally) the continued and shared care of patients, the
inspection of health services, health management and planning, and scientific
research, advise that a basic law considers and regulates the cases and circumstances
in which access to clinical information would be possible. It is necessary to establish
legislation to protect the privacy of patients in order to ensure no one is discriminated
against due to information related to health and to safeguard medical secrecy,
through the development of articles 14 and 18 of the Constitution.
49
50
The Stance of the Organización
Médica Colegial de España
regarding Collegiate Members
with Addictions or Mental
Illnesses: Help Methods and
Rehabilitation
51
and Endorsement):
THE STANCE OF THE ORGANIZACIÓN MÉDICA COLEGIAL DE ESPAÑA
REGARDING COLLEGIATE MEMBERS WITH ADDICTIONS OR MENTAL
ILLNESSES: HELP METHODS AND REHABILITATION
I. Justification
1.
Doctors, like other human beings, are not exempt from suffering a mental illness or
developing an addiction to alcohol or other drugs throughout their professional life.
The most recent data indicates that, in our country and at some point in their lives,
around 11% of doctors suffer from psychological disorders or addiction: of these, 60%
will experience mental health problems, 26% will experience alcohol addiction and
14% will experience an addiction to other drugs. These figures are not surprising when
the fact that 30% of doctors present chronic symptoms of professional exhaustion is
considered.
2.
In many cases, the doctor is not conscious of these problems and he does not request
help from other colleagues; in other cases, and with great effort, he attempts to hide
them so he does not have to resort to specialised care. It is then a question of time
before conflicts with colleagues or patients to whom he must provide care arise.
Regardless of the repercussions these problems may imply on familial and social
settings, these disorders exercise a negative effect over the occupational setting, both
in relationships with colleagues and, more seriously, in patient care, resulting in the
increased risk of negligence and errors.
3.
This Declaration aims to contribute to the mission of the Organización Médica Colegial
de España (Spanish Collegiate Medical Association) to monitor the correct practise of
the profession by its members and provide them with the support and help means to
do so.
II. Professional and social considerations
4.
For the purposes of the present Declaration, the sick doctor is considered to be a
doctor who may see his professional practise negatively affected due to psychological
52
problems and/or addictive behaviour with alcohol or other drugs, including moodaltering drugs. This state leads to: 1) denunciations due to malpractice, trials and
occupational conflicts; 2) long-term medical leave; 3) states of permanent incapacity
or professional disqualification.
5.
This situation can be reached due to diverse reasons:
•
•
•
•
•
•
•
•
•
The doctor works with people who suffer and ask for help, which results in
significant emotional exhaustion.
Intense stress during the training period.
Problems are frequently not resolved, or at least not completely, which results
in frustration.
An increase in the number and amount of trials due to negligence has created a
climate of fear and insecurity regarding potential medical errors.
There are significant social requirements that are not in proportion with what
the doctor can offer.
Health has become a political object on which the authorities impose
unreachable savings and productivity demands.
Doctors have changed from enjoying elevated social consideration to a
situation of less prestige.
Lack of self-esteem caused by the bureaucratisation of the doctor, which has
resulted in a loss of control over his work and salary.
Easy access to substances that can be abused and mood-altering drugs.
6.
In recent decades, the situation of the “welfare state” has resulted in society failing to
find meaning in suffering and, therefore, it does not tolerate it: suffering is a failure of
science and, consequently, of the doctor, who is blamed. A loss of perspective
regarding values has occurred, resulting in prioritising in excess the apparent and
social (quality, economy, efficiency) over the ethical (generosity, honesty, solidarity).
7.
The climate of hostility that dominates current society is gradually infiltrating the
occupational sphere, experiencing it as a normal state; there are many physicians who
remain in silence although they are the frequent subject of hostile attitudes that check
the normal development of clinical activity and professional promotion, shutting the
doctor off in mental alterations that drive him to mental breakdown, a feeling of
inability or accentuated limitation, with an impression of exhaustion, laxity and
despondency. These doctors end up doubting their own psychological abilities and,
generally, they head towards the loss of self-esteem, self-exclusion, somatisation,
alterations to the state of mind and, occasionally, to suicidal behaviour. The suicide
and suicide attempt rate for male doctors is between 1.7 and 3 times greater than that
of the general population and between 5 and 7 times greater in female doctors; the
53
suicide risk factors are mental disorder, especially depression, drug abuse and
underlying personality traits.
8.
The sociological studies carried out in different European countries in order to discern
the level of satisfaction of doctors with their professional situation offer some
alarming figures of dissatisfaction and disillusionment. It is true that the degree of
dissatisfaction is only moderate in some countries, but it reaches extreme levels in 1015% of doctors, for who the term “burn-out syndrome” has been coined as a
consequence of work-related stress, in whom work dissatisfaction is accompanied by
anxiety and disinterest in the practise of the profession.
III. Deontological considerations
9.
The Code of Ethics and Medical Deontology (1999) specifies:
•
•
Article 19.2: If a doctor were to note that, due to reasons of age, illness or other
causes, his judgement or technical skill is deteriorating, he should immediately
request the advice of a trusted colleague to help decide if he should temporarily or
definitively suspend or modify his professional activity.
Article 19.3: If the doctor is not conscious of said deficiencies and they are noted
by another colleague, the colleague is obliged to communicate this to the doctor
and, if necessary, notify the medical association objectively and with due
discretion. This action will not imply a failure to fulfil the duty of fraternity as the
wellbeing of patients is always the priority
10. Article 42 of the General Statutes of the Organización Médica Colegial de España
establishes the prohibition of practising medicine when organic or psychological
alterations or toxic habits that incapacitate the doctor for said practise, prior to the
pertinent medical examination, become evident.
11. The sick doctor is usually incapable of recognising that the problem exists and his
colleagues maintain an unspoken pact of silence. It is not ethical, nor is it
deontologically correct, for a doctor to act as a mere spectator in the face of the unjust
actions of others on the work team towards a colleague; this behaviour is highly
destructive from a psychological point of view.
12. In conclusion, there are a variety of reasons to intervene without delay in these cases:
1) High pathological prevalence that increases every day;
2) Strong resistance of the addicted or sick doctor to asking for help, whether
in the short or long term;
54
3) Risk of malpractice and its serious consequences that have already been
explained;
4) Deontological obligation to quickly and efficiently assist the sick colleague;
5) Intervention is efficient, considering the number of rehabilitated cases is
higher than in the rest of the population.
IV. Practical aspects
13. The actors who should intervene in the case of the sick doctor are the family,
colleagues, the company, the health administration and the medical association.
14. To ensure a help and rehabilitation programme for a sick doctor is successful, the
following is necessary:
a. Guaranteeing utmost confidentiality.
b. Care must be different to general care services, specific to attending a
doctor and highly specialised.
c. The medical association must exercise its responsibility over the selfregulation of the profession and act as guarantor for good practise,
monitoring the practise of medicine on the doctor in rehabilitation.
d. Using the figure of the “therapeutic contract” in diverse degrees as a
reflection of the mutual commitment between the sick doctor, the
therapist doctor and, occasionally, the medical association and/or
administration or company.
15. In cases of doctors with high-risk psychological disorders (depression, substance
abuse), or in life-changing situations, their access to collegiate or professional mental
health services with the necessary legal protection must be encouraged.
16. There is a series of factors that must be actively tackled and which complicate the
treatment of the doctor in a situation of addiction:
•
•
•
•
•
•
The conspiracy of silence: the problem being hidden by the sick person,
their family and colleagues.
Fear of stigmatisation due to the kind of illness, even between
colleagues.
Fear of the loss of credibility and reputation (tarnished exemplariness).
Fear of being recognised or confidentiality being infringed upon (fear of
the waiting room).
Fear of not returning to professional practise.
Therapeutic arrogance, the myth of invulnerability and not wanting to
assume the role of patient.
55
17. Medical colleagues with addictions encounter a series of obstacles that must be
eliminated in order to efficiently help them:
•
•
•
•
•
Tolerant attitude.
Fear of causing harm.
Silent agreement.
Lack of ability to confront the situation.
False respect of privacy.
18. In the case of physical and verbal abuse given by patients, the doctor must lodge the
claim meaning, in addition to putting up with the abuse and post-traumatic stress this
leads to, he must bear the stress of the trial; the lack of security in his private life adds
to this when the aggressor knows the personal details for the complaint. Given that, in
compliance with the duty of protection, the company or administration must
guarantee the health and safety of workers in its service in all aspects related to their
work, the management team for the health centre must undertake the presentation of
the claim so the privacy of the abused doctor may be safeguarded.
19. The Organización Médica Colegial de España has the obligation to urge (articles 3.1
and 42.b of the General Statutes) the health administration to implement the
preventive measures that are established in article 15 of the Occupational Hazard
Prevention Law from different management positions.
56
V. Conclusions
20. The obligation of the doctor is to care for the health of his patients; to be aware of the
health of colleagues with whom he relates is an even more serious and pressing
obligation. Passiveness regarding a sick colleague is regarded as improper conduct,
given the potential for harm to patients and colleagues, and it constitutes complicity in
the harm caused by the sick doctor.
21. The Organización Médica Colegial de España is the guarantor for professionally,
ethically and deontologically correct medical actions. To ensure these actions take
place, suitable family and work centre collaboration is necessary.
22. Cases of doctors with addiction problems or mental illnesses known by the board of
directors at medical associations or by ethics and deontology commissions must be
assessed by competent colleagues with experience in this field in order to establish a
personalised treatment and rehabilitation programme. In these cases the application
of the PAIME (Programa de Atención Integral al Médico Enfermo – the Programme for
the Full Care of the Sick Doctor) has proven to be of great help and efficiency.
23. The Organización Médica Colegial de España has the duty to pressure colleges to agree
with the respective administrations in order to implement PAIME in all autonomous
regions.
57
58
The Involvement of Doctors
with the Media in Cases of
High Public Interest
59
The General Assembly of the Consejo General de Colegios Oficiales de Médicos (General Council of
Official Medical Associations), hosted on 17 September 2005, adopted the agreement to approve the
following declaration drawn up by the Comisión Central de Deontología, Derecho Médico y Visado
(Central Commission for Deontology, Medical Rights and Endorsement):
THE INVOLVEMENT OF DOCTORS WITH THE MEDIA IN CASES OF
HIGH PUBLIC INTEREST
1. It is obvious that today in the public, an unprecedented interest in health matters and
medical advancements exists. Health and science sections or supplements of the
media try to satisfy this interest while constantly maintaining it with news and new
comments.
2. It is natural that, at the origin or clarification of this news, doctors play an important
role. In fact, some present health information programmes aimed at the wider public,
or they collaborate on them in a constant manner. Furthermore, it is not uncommon
for doctors or centres to hold press conferences to divulge news about new
technology or therapeutic novelties. Other times, collegiate members may be invited
to participate in different kinds of programmes. Therefore, they participate by acting
as experts who give or assess information regarding current medical issues; or by
merely being the doctors who treat groups of patients that are “in the news” due to
their status as victims of accidents or epidemics.
3. When appearing before the media, doctors must always consider the duties
professional deontology and social ethics impose upon them. They must appear, at all
times, as objective and prudent. They will never be permitted to raise false hope or
propagate unfounded concepts, nor may they harm the confidentiality they owe their
patients and colleagues or the health institutions in which they work. When they
speak about their own professional activities, they must do so with strict veracity and
deliberation (articles 38.1 and 38.2 of the 1999 Code of Ethics and Medical
Deontology).
4. Zealously respecting and protecting the patient’s right to privacy, professional secrecy
and respect for colleagues is a medical duty that must be fulfilled with particular tact
and thoroughness. The doctor professes the profound conviction that patients are the
owners of the information that concerns them and, therefore, patients have the
power to withhold or divulge it. The doctor will be able to reveal said information
60
appropriately when his patients ask him to act as their spokesman and to speak on
their behalf.
5. It has become normal that the information about patients who are admitted to a
hospital due to accidents or catastrophes is offered by the director of the institution
who, in this capacity, presents it before representatives of the media. This information
must be adapted to the guidelines of good professional practise. This is not difficult
when it consists of simply reading something or responding verbally to the questions
of journalists regarding the situation of a group of people. When informing about
individual patients, not only must the director have the authorisation of the patient,
he must also refrain from offering diagnostic or prognostic assessments without the
knowledge and authorisation of the doctor responsible for the patient.
6. Extreme caution should be taken when television cameras attend the scene of an
accident or enter emergency areas or hospital wards. The doctors responsible or the
directors of health institutions must oppose, with the necessary force in such sensitive
and particular circumstances, the fact that patients’ privacy and that of their close
family may be harmed or a lack of respect is shown to the professionals attending
these patients.
7. Finally, it must be highlighted that information about violent or presumably criminal
actions (abuse, poisonings, murders) is a matter for the police, not doctors. Doctors
are obliged to treat all patients with the respect and discretion that are due to all
human beings. Doctors are not responsible for determining the legal significance of
the injuries they observe and treat, nor are they responsible for the reasons that led to
an individual causing said injuries to another person, given that this is the
responsibility of legal professionals.
Madrid, 19 September 2005
61
62
The Ethics of the
Professional Relationship of
the Doctor with the
Pharmaceutical Industry
and Health Companies
63
Official Medical Associations), hosted on 12 May 2006, adopted the agreement to approve the
THE ETHICS OF THE PROFESSIONAL RELATIONSHIP OF THE DOCTOR
WITH THE PHARMACEUTICAL INDUSTRY AND HEALTH COMPANIES
1. Upon becoming a collegiate member, the doctor publicly accepts the deontological
commitment of providing human and scientific care to his patients (Code of Ethics and
Medical Deontology, article 18). This implies an ethic of prescription based on the
principles of freedom, as developed by the Comisión Central de Deontología (Cental
Commission for Deontology) in its Declaration on the Doctor’s Freedom of Prescription
(1998), approved by the General Assembly and published in the Organización Médica
Colegial de España (Spanish Collegiate Medical Association)’s journal, no. 62 (February
1999). In this declaration, it is established that the freedom of prescription is linked to
professional responsibility, which implies the application of a therapeutic or diagnostic
measure must be preceded by a consideration of its scientific validity, its suitability to
a certain patient and its efficiency. The Declaration refers expressly to the economic
aspects of medical decisions: “The doctor must not forget that the money that must
be paid for prescriptions is not his, it is that of the patient or the institutions
responsible for them, and he must make rational use of it (…). This deontological duty
of prescribing with rationality and economic sense obliges the doctor to be fully
independent of restrictions that limit his freedom to do his best in each case, as well
as his economic best, for his patient or the person who is responsible for the costs."
2. The profound changes experienced by the health organisation in recent decades has
placed efficiency and the economic factor in a significant position regarding medical
decision making, which may be the subject of interference due to interests that do not
always coincide with those of the patient, who is the main subject of healthcare. As
such, at least two agents related to the doctor who decides on the prescription or
makes decisions with economic implications and who, in some circumstances, may be
unduly influenced by the interests of the service provider organisation (whether it is
public or private) and/or the health industry or company, may become involved in the
process.
64
3. Therefore, the ethical problems or conflicts of interest for the doctor whose behaviour
must be guided by the principles of professional independence, loyalty to the patient
and transparency in society are laid out. The exemplary behaviour of the doctor is an
extremely relevant moral value in laying the foundations of trust in the clinical
relationship and social respect for the medical profession.
4. The Comisión Central de Deontología feels the need to offer collegiate members some
ethical and deontological criteria that may contribute, along with other agents
involved (health administration, pharmaceutical industry, health industry, scientific
societies, patient associations, care organisations) in the social deliberation of an issue
of great interest and with serious implications for the common good.
5. The relationship of the doctor with pharmaceutical and health companies must be
regulated by the principles and values that are characteristic of the medical
profession: scientific thoroughness and rationality, a spirit of cooperation, a sense of
serving patients and responsibility for society. This commitment of the doctor’s
professional loyalty must also inspire his relationships with health service providers,
whether they are public or private entities.
6. Pharmaceutical companies have legitimate commercial interests: the promotion of
their products via traditional information and advertising strategies that are ordinarily
accompanied by commercial attention. In Spain, a law (Royal Decree 1416/1994)
exists, detailing the limits and value of gifts and the hospitality that a doctor may
accept. In addition to what is established in the legal regulation, the doctor will strive
to maintain an attitude of elegance and seriousness in the face of commercial
attention and will prudently avoid any sign of advertising ostentation towards
patients.
7. It is acceptable, and even necessary, that the pharmaceutical industry organises and
finances scientific and training activities that are an essential and valuable element of
continued medical education. However, it must not be forgotten that this is a primary
ethical obligation of the doctor, for whose practical development the institution in
which the doctor practises his professional activity, whether exclusively or mainly, is
responsible.
8. Doctors who assume management responsibilities in scientific and medical training
activities that receive financing from private commercial organisations must guarantee
the independence of the content of the programmes they develop, and they will
65
express with clarity and transparency the nature of the financing received. The
minutes of a scientific meeting dedicated to the promotional information of a product
or procedure will remain clearly defined. The doctor who participates in these events
as an expert must demand all such actions be declared in this way.
9. The information of the industry that facilitates the technology transfer of a new health
product or a new guideline with the potential for providing added value to the quality
of care is highly valuable. However, the practise of making medical professionals the
subject of promotional strategies that are merely repetitive and which try to obtain
the greatest number of publicity “hits” is reprehensible. The doctor must analyse the
time he invests in receiving information from the pharmaceutical industry in
accordance with efficiency criteria. He must maintain a relationship based on
usefulness, courtesy and professional respect with representatives of the
pharmaceutical and health industry.
10. Requesting or accepting remuneration in exchange for prescribing a medication or
using a health product is incompatible with medical deontology. This essential ethical
principle does not permit exceptions concealed in supposed research studies, for
example, pharmacovigilance, which leads to certain prescriptions being prescribed.
This criteria must also contribute to reflection – both that of the individual doctor and
that of medical groups – when establishing collaboration agreements with the health
industry in order to facilitate attendance at conferences, training activities or any
other kind of assistance.
11. Doctors with management responsibilities related to the acquisition of health supplies
have a deontological duty to exemplariness that surpasses the minimum level required
by legal guidelines, regarding doctors and staff at the institution as well as users.
Direct incentives of prescription – whether positive or negative – are also contrary to
ethics when they originate from the health centre’s managers, and are especially
reprehensible if promoted by professionals who are obliged to observe medical
deontology guidelines.
12. Cooperation between the medical profession and the health industry is necessary in
all stages of the development and use of medication or any other health material in
order to guarantee the safety of patients and the efficiency of treatments. The doctor,
who has the right to receive reasonable compensation from the industry for his work
as a researcher, consultant or teacher, also has the correlative right to declare these
links whenever appropriate and he will also complete the corresponding disclosure of
66
interests, especially when publishing kinetic results. When a doctor participates in a
scientific research project promoted by a pharmaceutical company, his participation
must be conditional to having full freedom over its publication, whether the results
are favourable or not from the promoting company’s perspective. The doctor who, in
his role as expert, makes recommendations in scientific mediums as well as the
general media must make his links, if any, with the industry clear.
13. Currently, the health administration in Spain dedicates scarce resources to the
continued training of doctors and it leaves a large part of its financing in the hands of
the pharmaceutical industry. In this situation, and bearing in mind the salaries doctors
in Spain receive, it is understandable that many doctors who, in order to access the
necessary updated professional training, turn to the help of the industry, without
which medical conferences would be impossible. For these reasons, and while the
situation remains unchanged, it is recommended that doctors seek advice from the
deontology commissions of medical associations before determining their
relationships with the pharmaceutical and health industry.
14. Some scientific organisations and medical institutions are recommending that their
members compile records of collaborations and voluntary disclosures of interests,
which would be exemplary behaviour related to promoting transparency regarding
essential ethical criteria in the relationships of doctors with the pharmaceutical and
health industry.
15. The Comisión Central de Deontología urges those responsible for medical training,
particularly that of medical students, to introduce in faculties, from the first years of
study, these ethical values.
Madrid, 16 May 2006
67
68
Declaration on the Qualities
of the Medical Certificate
and its Differences to
Medical Notices and
Reports.
The Peculiarities of the Medical
Death Certificate.
69
Declaration on the Qualities of the Medical Certificate and its
Differences to Medical Notices and Reports.
The Particularities of the Medical Death Certificate.
Introduction
There are many social circumstances in which it is necessary to have a sure, truthful and
precise testimony regarding citizens’ illness and health situation. As such, society needs to
make use of doctors and consider them as unique experts in the assessment and judging of
states of health and illness.
Doctors have the legal and social obligation to certify. To do so correctly, they need, in
addition to exercising their scientific knowledge, to fulfil the requirements imposed by legal
technique and professional prudence. In order to recall the most basic ideas that must be
considered regarding the matter, the Comisión Central de Deontología (Central Commission
for Deontology) has prepared this Declaration.
It has done so as certification is a medical act that is subject to the demands outlined in
statutory and deontological guidelines and, in particular, the guidelines established in Article
VI of the General Statutes (articles 58-61) and in the current Code of Ethics and Medical
Deontology of the Organización Médica Colegial de España (Spanish Collegiate Medical
Association) (article 11); which, if necessary, establishes the deontological codes of the
autonomous councils of medical associations.
With the present Declaration, the Comisión Central de Deontología wishes to complete
current doctrine given its previous declarations on the matter: on medical certification, on
self-certification, and on the ethics and deontology of medical leave and end of medical leave
certificates in primary and specialised care and the role of medical inspectors in their control
and supervision. All of these declarations were approved by the General Assembly at the
Comisión Central de Deontología sessions on 8 October 1992 (the first two declarations) and
on 26 May 2001 (the last declaration).
It is hoped that this declaration results in an increase in the quality of the documents that
certify the observations of doctors, a task that is necessary for the good functioning of
society.
1. Preliminary clarifications
1.1. Among the documents the doctor issues, there are a few whose purpose is
70
essentially care-based and they look to improve the clinical care of patients,
while others, of a legal nature, have a purpose related to the exercising of a
right or the fulfilment of an obligation, and legal consequences, not only care
effects, are often derived from them.
1.2. The main kinds of these documents are:
Medical report. This is, by definition, a brief document that serves to make an
authority or the general public aware of a medical act such as a clinical or care
situation.
Clinical report and medical certificate. These are documents that provide
information about personal details of a health nature. They aim to legally or
administratively accredit, before third parties, a state of health or illness, or a
provided care process. They differ due to their supporting material, the purpose
for which they are requested, the temporary validity of the details they accredit,
and the type of medical act they testify.
1.3. Both the medical certificate and the clinical report are frequent legal
requirements that may be requested to verify the state of health or illness for
the purpose of opting for certain benefits, or exercising certain activities, or
accrediting facts of civil importance. Consequently, they must comply with the
guidelines that regulate these services and activities. The issuing of these
documents is, to a certain extent, a public service. As such, it must not be
forgotten that their issue is a legal obligation of doctors and a patient right.
1.4. These public and legal implications justify the need to have suitable knowledge
about what these documents are. It is advisable not to forget that the
incorporation of the expression “I CERTIFY” in a medical report provides it
legally with the value of a certificate and grants its content a testimonial
supplement of guarantee and commitment.
2. Features of the medical certificate
2.1
A medical certificate or medical certification is understood to be the document
issued by the doctor that aims to provide evidence of certain actions related to
the health, illness or care received by a patient. The request for medical
certificates is generally determined by legal guidelines that require citizens to
present this document so they may opt for certain services, activities or
benefits, or for the qualified accreditation of personal details or civil situations
(for example, birth, death, disability, psychological state, sporting ability).
2.2
The medical certificate is always extended to the request of the interested
party, understood as the patient, the person who the patient authorises in
writing or the accredited legal representative. In the case of sick patients who
71
are incapable of performing this action, a family member who occupies
representation may request certificates; if the patient is a minor, his parents or
legal representatives may request these certificates. If the minor is over 16
years old and is emancipated, the regulations that apply to adults will apply.
2.3
With regards to the request of a medical certificate or report made by
insurance companies, the following regulations must be observed:
a) The issue, by the doctor who usually attends a patient, of medical certificates
or reports to an insurance company requires the informed and express
consent of the patient. Without this consent, the doctor may not provide
such information. The transfer of this information must be made in
conditions that guarantee its confidentiality, meaning it is advisable that
these documents are sent to the medical services of the insurers.
b) If the doctor performs the medical check on the patient under the orders of
an insurance company, he must inform the patient before acting in the role
by virtue of which he is acting and that his report and conclusions will be
delivered to the insurer. The patient has the right, before the report is sent
to the company, to be informed of the results of the examination and to be
warned of the consequences that the sending of these may result in.
2.4
As a general rule, self-certification must be considered contrary to professional
ethics.
2.5
The medical certificate must be submitted only to the patient, the person who
has legally requested it, or to the person who has been authorised to receive it
on behalf of the patient.
2.6
The certificate is a document that is not addressed to anyone in particular. It
obliges the consideration that, independent of the explanation given by the
legitimate requestor, the certificate may be used for any other purpose, which
requires extreme prudence in both the structure and content of these
documents. This highlights the need to follow strict criteria of exactness,
terminological precision and circumspection, avoiding any kind of complacent
distortion or ambiguity of the medical fact observed.
2.7
The medical certificate must be issued on the official paper edited by the
Consejo General de Colegios Oficiales de Médicos de España (General Council
for Official Medical Associations in Spain). The law may permit the use of other
kinds of paper.
2.8
The issuing of certificates is a professional obligation derived from the legally
recognised right of the patient to obtain medical certificates accrediting his
state of health.
2.9
The doctor is not obliged to issue a certificate if the lack of specific competence
72
or a lack of data or tests does not enable him to confirm the facts that would
need to be accredited. Many problems of this nature, which may present
themselves in very different situations, may be derived from people or
institutions established by society (medical certificate of sporting ability,
immigrant request to obtain residency permits, certification of capacity for
certain functions, commencement of a disability application).
2.10 When established by a legal or regulatory disposition, the issuing of certificates
by the doctor is free. In such a case, doctors in private practise will only be able
to charge professional fees for the examinations and checks they must
perform. Doctors who provide care in public centres or on behalf of third
parties may never charge professional fees, given that the issuing of the
certificate falls under the concept of the health service. Doctors who provide
services for insurance companies must address the guidelines determined in
the policy purchased by the requestor.
2.11 The official medical certificate serves to prove a current and contemporary
state of health, which is reflected in the date of request and issue of the
document.
2.12 The medical certificate is subject to the regulations of professional
responsibility. A lack of accuracy or truth in a medical certificate may imply
legal liability, in accordance with the guidelines established in article 397 of the
Criminal Code, and civil liability, with the obligation of repairing the damage
caused. The failure to fulfil what is established in article 11 of the Code of
Ethics and Medical Deontology constitutes a deontological infraction, which
may be sanctioned in accordance with what is established in the Statutes of the
Organización Médica Colegial de España.
2.13 Considering its content is a guarantee of a fact, medical certificates for nonexistent illnesses are ethically and legally prohibited.
3. Peculiarities of the medical death certificate
3.1 This is a legally obligatory medical document that the Civil Record Law
denominates a medical death report which must always be issued by a doctor.
The doctor who attended to the patient during the process that led to death, or
the doctor who was present in the patient’s final moments, or the doctor who
attended to the patient during his final illness, must be the one to issue it. Only
as a last resort may any other doctor who has seen the body and may reliably
reconstruct the mechanisms of death issue the certificate.
3.2 The medical death certificate may not be issued in cases of violent death or
suspicions of criminality. In such circumstances, the doctor must draw up a death
73
certificate addressed to the magistrates’ court so the legal autopsy may be
performed.
3.3 In addition to the identification details of the doctor and patient, the medical
death certificate must also include the immediate and fundamental causes of
death and the time of death.
3.4 The death certificate must always be printed on the official paper distributed by
the medical association. Its issue is free. The individual human circumstances
that surround the death of a person would consider the charging of professional
fees to certify death a particularly degrading action of abuse. The practise of this,
which has been introduced in some places by funerary agencies, must be
vehemently rejected.
4. Medical reports
4.1 The medical report is a document through which the doctor responsible for a
patient, or the doctor who has attended a patient during a certain care episode,
makes known the medical aspects related to the disorders the patient is
suffering, the diagnostic methods, the applied treatments and, if applicable, the
functional limitations they may result in.
4.2 The medical report serves to place on record a state of health, even prior to the
date of request. Its validity, therefore, is not limited to a period of time.
4.3 The request for a medical report may be linked to reasons of individual interest
or legal or public order.
4.4 The value of proof and guarantee that the legal order and society confer on
medical reports obliges extreme thoroughness in the preparation of its content
and the use of ambiguous terms or insufficient or excessive information that
may confuse the addressee must be avoided.
4.5 Medical reports must include the end of medical leave report, which is the
document issued by the doctor responsible when each patient’s care process at
a health centre is finalised and which also includes, in addition to a brief
summary of the clinical history, the data that is most relevant to the care activity
provided during the patient’s hospitalisation, and the corresponding therapeutic
recommendations.
5. Ethical recommendations
5.1 Medical reports or certificates must only be issued at the request of the patient,
and, in his interest, at the request of the person who the patient has authorised
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for such a purpose.
5.2 Never will a certificate be granted for facts that have not been observed or
personally checked. When the certificate includes declarations made by the
patient or inferences that the doctor makes from clinical data, this decisive
circumstance must be expressly mentioned.
5.3 What has been observed must be described with accuracy and thoroughness,
using precise and prudent expressions that are free of personal comments.
5.4 The use of technical terms must be avoided as much as possible; if their use is
inevitable, a clarification must be given as to their meaning in order to make them
understandable in common language.
5.5 Medical reports or certificates must not include deontological or legal assessments
of the confirmed facts, nor critical evaluations of the actions of the professionals
who have intervened. In a medical certificate, expressions that may discredit or
cause a loss of prestige to other doctors are out of place.
5.6 The date the certificate is issued must be noted, followed by the signature of the
doctor who certifies it.
5.7 It is recommended that a summary of the documents that have been delivered to
the patient is recorded in the clinical history, indicating the reason they have been
issued. It is also recommended that a copy of them is kept.
5.8 Whenever a medical certificate or report is prepared, the doctor must consider
that the document may be presented anywhere, resulting in different effects to
those related to the purpose for which it was initially requested. As such, it is
recommended once again that no form of medical documents for a non-existent
illness are issued.
Madrid, 21 November 2006
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76
Declaration on the Clinical
History: Ethical and
Deontological Aspects
77
Declaration on the Clinical History: Ethical and Deontological
Aspects
I. Introduction
1. Efficiency in medical care demands that all data related to the health and illness of a
patient remains collated in a document which, at a particular moment, may be
consulted by the doctor or by another health professional. As such, this guarantees
continuity in care, the possibility of following the development of the patient, and the
objective safeguarding of the data supplied by the patient and his family members, in
addition to complementary observations, examinations and data.
2. New forms of medical practise, the different kind of doctor-patient relationship, and
the changes operated in the paradigms that govern this relationship require a fresh,
more formal and more complex document model in which not only doctors
participate, but also other health professionals. The practise of this type of medicine
has broken, to a certain extent, this private and personal relationship of a doctor with
his patient, allowing other people who are not necessarily from the health stratum to
participate in the privacy and secrets contained in the history which makes
maintaining professional secrecy more difficult. However, the fact that the clinical
history passes through many hands may not be to the detriment of the scrupulous
safeguarding of confidentiality and secrecy regarding its contents.
The deontological principle from which the clinical history is prepared and conserved
for the care of the patient is sacred and must take precedence over any other right.
Every time a clinical history is reopened, for the purpose of a new pathological
process, the review of previous entries, or for scientific, research or legal reasons, it
must be done under the same ethical and deontological principles that inspired the
first time during which the presence of the patient initiated this document.
The clinical history of a patient is continuous, although each medical act reflected
there is a unique act in itself, with the doctor who carries out the act responding to it,
but it is an indivisible whole regarding the data reflected therein, whose confidentiality
is governed by moral and legal law.
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3. The need to preserve and guarantee the rights and duties of patients, doctors and
even third parties who may find the clinical history to be a documented source for
other intentions that differ to the care purposes but which are equally legal and
legitimate has resulted in a guideline that regulates this complex document being
necessary, not only in clinical and deontological aspects, but also in administrative and
legal matters.
The fact that an extensive legal regulation exists, which fortunately goes hand in hand
with deontological guidelines, must be understood from the requirement of the legal
protection of all interests in play, some of which are of maximum standing when they
impact on personality rights that are protected by the first title of the Spanish
Constitution as fundamental rights. However, it must always be remembered that the
clinical history is, above all, a clinical document that is subject to the regulations of the
medical art and the medical deontology that governs it.
4. The conflicts that are generated in its interpretation are important, therefore different
forums have demanded, from this Comisión Central de Deontología (Central
Commission for Deontology), a document in which a medical and deontological
interpretation of this matter is made in light of the Code of Ethics and Medical
Deontology (CEMD).
5. As article 7 of the CEMD highlights: “Efficient medical care requires a full relationship
of trust between the doctor and his patient.” Knowledge of a sick person’s problems
and ailments is only possible if the sick person entrusts them to his doctor
unreservedly, in the full knowledge that these declarations, which are sometimes
banal or sometimes important, remain preserved under professional secrecy. The
doctor who edits or consult a clinical history may never forget that the property and
values contained in the history are of extreme importance as they are directly related
to one of the fundamental rights of the individual: the right to privacy from which
other, no less important rights, stem, including the rights to honour, dignity, freedom,
physical integrity and health.
6. The Comisión Central de Deontología, without ignoring legal regulations in this matter,
has deemed it necessary to articulate the ethical nature of the clinical history and the
situations that, in its clinical environment, may arise, solemnly declaring that: if a
doctor were to be sure that some particularly sensitive information – that due to
special relevance and significance must never be revealed – were not going to be
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safeguarded with the necessary guarantees, he must not record it in the history,
although this is to the detriment of care.
II. Nature of the clinical history
7. The clinical history is an essential document in which the doctor-patient relationship is
captured, given that it expresses the free and voluntary declaration of the sick person,
sometimes stating intimate feelings as he experiences them. The clinical history must
collate the anamnesis and patient examination data as well as the conscious and
voluntary acceptance of the examinations and consultations proposed, refusals to
receive treatments or the denial of certain types of examinations. The clinical history
may gather information provided by family members or common-law relations as long
as it is in the interest of diagnosis and treatment. Finally, the doctor may capture
opinions in order to justify a certain decision. He will be obliged, without prejudice to
the duties of other professionals, to record the development of the sick person in the
clinical history and as many events and incidents as are relevant to the care process.
The notes that are taken must be relevant to the care process, and truthful and
respectful towards the party involved and his family. It is not ethical to filter or modify
clinical data in consideration of a possible legal complaint.
8. It is a deontological and legal mandate that all medical acts in the course of a care
process are faithfully reflected in the patient’s clinical history, with the doctor having
the duty and unavoidable right to record them (article 13.1 of the CEMD). The doctor
is the person who is ultimately responsible for its editing and updating, and he should
enrich it with his scientific and personal contributions, and he is obliged to safeguard
the secrets he knows, whether he has garnered knowledge of them directly from the
sick person or through other colleagues or through consulting the clinical history of
the patient. Not even the death of the sick person will excuse the doctor from this
obligation (articles 14 and 15 of the CEMD and article 18.4 of Law 41/2002 on Patient
Autonomy and Rights and Obligations regarding Clinical Information and
Documentation).
9. The essential objective of the clinical history is to facilitate and support the patient’s
healthcare. Therefore, it must contain all the data and information generated at each
of the medical acts in which the patient has been involved throughout his life.
Likewise, the clinical history must contain the examination results and data that have
been obtained even when these are normal or were negative. It must not be assumed
that, if they are not recorded, the findings were normal or negative. It must contain
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the data that justifies the diverse diagnostic and therapeutic procedures employed as
well as the documents accrediting the fact the information was received by the patient
and that his consent to said procedures was granted.
The doctor must ensure the advance wishes and decisions the patient has declared
remain recorded in the clinical history in a visible place for immediate and/or urgent
consultation.
10. Language must not be a barrier between the patient and his doctor, nor must it be an
obstacle to the clinical history being consulted by other colleagues. The person who
edits the clinical history must be aware that the data he records is essential to treating
the patient and that it will be consulted in the future by another doctor, therefore it
will be vital. As such, it is an ethical requirement that lexical care is taken, particular or
local terms are not used, abbreviations are not used although their use may be
common, and writing is legible.
11. Working in a team, both in health centres and the hospital, means that different
doctors may have access to the clinical history during the same process. The author of
each medical act must remain unequivocally identified in the history as only he must
ethically and legally respond for said act. Diagnostic and therapeutic discrepancies
may and should be recorded in the history but the composure inter-professional
relationships require must be maintained and this document must be converted into a
means by which differences that are not related to the clinical case are resolved.
12. The doctor, due to deontological and legal mandate (article 13.2 of the CEMD) and, if
applicable, the institution in which he works are obliged to put into practise the
measures to ensure: clinical documentation is preserved, and access and unauthorised
use of it, the falsification or elimination of data, theft, the malicious adulteration or
loss or accidental destruction of the clinical history during the time its preservation is
deemed necessary, which will never be inferior to five years (article 17 of Law 41/2002
on Patient Autonomy and Rights and Obligations regarding Clinical Information and
Documentation), is prevented.
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III. Ownership of and access to the clinical history
13. Considering the essential purpose of the clinical history is to facilitate medical care,
any use of the history for a purpose that differs to this must fulfil, in principle and with
minimum exceptions, two ethical requirements: confidentiality must not be violated in
any case and the consent of the patient and doctor must be granted (article 13.4 of
the CEMD).
14. Article 18.1 of the Spanish Constitution guarantees the right to personal privacy and
own opinion as fundamental rights. However, as the doctrine of the Constitutional
Court establishes that these rights are not absolute. Occasionally, the staunch
protection of these rights may conflict with the general interests of society or third
parties, which means a solution to this problem, causing the least harm possible, must
be found. The constitutional doctrine establishes that when fundamental rights are
harmed for the benefit of the common good, this harm must be kept to a minimum
following strict criteria of proportionality: the harm caused must not be greater than
the benefit that is hoped will be obtained upon violating said right. Without prejudice
to the guidelines established in other regulation, it is Law 41/2002 that positively
develops aspects related to the clinical history. In its article 7.1, it states: “every
person has the right to the confidential nature of his health-related data being
respected, and that nobody may access this data without prior authorisation
protected by the law.”
Therefore, only in very specific situations, when the public or common good must
prevail over the good of the individual and the principle of justice is imposed over that
of autonomy, will the doctor be able to reveal confidential details about the patient
without committing a deontological offense, but he will always do so in a restricted
manner, with discretion, and revealing only what is fair and necessary, and to the
person who is exclusively authorised by the law (article 16.2 of the CEMD). This is one
such case in which the doctor situates himself in the position of guarantor, especially if
the sick person may not represent himself.
15. The main doctrine among the treatise writers of Civil Rights in line with the General
Health Law, Royal Decree 63/1995 and some autonomous decrees is that ownership
of the clinical history pertains to the institution for which the doctor works. However,
it is unquestionable that in the writing of the history there are three actors with welldefined rights and obligations that enables a discussion of co-ownership.
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a) The patient is the essential element. Without him, there is no clinical history.
He actively participates, communicating his symptoms and his family and
personal background. He passively participates by allowing examinations on
him to be performed and by subjecting himself to the examinations that are
suggested to him. He gives the act legitimacy when he consents.
b) The doctor directs anamnesis, examinations, diagnostic tests and he performs
clinical judgement and suggests treatment. He is the guarantor for
confidentiality while the clinical history is in his power. He gives legitimacy to
the medical act by respecting the principle of patient autonomy.
c) The centre facilitates the material and human means so the medical act may be
carried out. Sometimes, it also facilitates the therapeutic means. Its legal
imperative is the obligation to safeguard the clinical history.
16. Given that none of the three parties has absolute control over the clinical history,
there will be rights of some that generate duties for the others.
a) Patient rights: The patient has the right to request that his data consists of a
history; the right to this being safeguarded with guarantees, materials and
morals; the right to consult it; the right to have a copy or part of it; the right to
delegate a representative so he may do so in his name; the right to authorise
its consultation to non-health staff; the right to prohibit third parties from
accessing it; and the right to decide the destination of it after his death. He is
obliged to be truthful in his declarations to health personnel.
b) The doctor has the right to write up the history of his patients and, as author of
the history, the right to have no one modifying, amending, substituting or
removing it. He has the right to exclusively reserve a space of confidentiality to
make his subjective annotations (article 18.3 in Law 41/2002 on Patient
Documentation: “nor to the detriment of the right of professionals who
participate in its preparation, who may oppose the patient’s right of access in
order to preserve their subjective annotations”); the right to limit the rights of
patients and the administration when, given his position as guarantor, he must
monitor the right to confidentiality of certain data pertaining to third parties
and that was brought to the clinical history in the clinical interest of the
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patient; and the right to select the information that must be supplied to a
judge and the health administration depending on the matter to be resolved.
c) The centre or institution has the right of ownership over the tests that are
performed at their expense; the right to define the manner in which clinical
histories should be classified and the type of support, as well as the right to
establish monitoring, usage and safeguarding systems (article 13.2 of the
CEMD).
17. In the clinical history, the relevant statements made by the patient regarding his
personal background and the details of third persons known to him, in general parents
and siblings (family background), figure but sometimes there are interpretations or
personal judgements made by the doctor responsible for the patient or the data and
opinions gathered by the doctor of family members or next of kin that are essential for
diagnosis but they must be kept secret from the patient, therefore it is advisable that
the patient does not have full and absolute access to the entire clinical history. For
example, knowledge of the patient’s alcoholism may be an essential piece of
information for the doctor who attends to him but the manner in which the physician
has had access to this information may create situations of conflict between the
patient and the informant, given that the doctor must record in the clinical history the
information source as it may be need to be checked at a certain time. Any information
from third parties that the doctor deems appropriate to include in the clinical history
of a patient must highlight the source it comes from and record it with prudence and
respect for both the patient and the other people involved (doctors or health
personnel) who may be involved in the patient’s care.
Occasionally, it is for the good of the patient that unlimited access to his own clinical
history is advised against. Certain psychological illnesses or certain genetic data, which
are included in the clinical history, may advise against the patient’s access to it,
considering they may not be correctly interpreted or they may create a situation of
anxiety and doubt regarding his future health.
IV. Third party access to the clinical history
18. If, in certain situations, it is permitted that the patient has restricted access to the
clinical history, this limitation must, with even greater reason, apply to other people
who may access the clinical history (doctors, nurses, administrative services,
inspection services, etc.). A doctor, simply for being a doctor, may not access any
84
clinical history if access is not motivated and based on the care of the patient, in the
measure required or in the undertaking of clinical or epidemiological studies that, at
the same time, have the authorisation of the corresponding Clinical Research Ethics
Committee (article 16 and Law 41/2002 on Patient Autonomy and Rights and
Obligations regarding Clinical Information and Documentation).
19. Judges may order the seizure or sending of a clinical history, especially when it is an
element of proof or conviction in a criminal matter. In such circumstances, the duty to
submit the clinical history will exist, under penalty of committing a crime of
disobedience. However, sometimes the judge is not interested in the entirety of the
history, but instead a part of it. In this case, the doctor must inform the judge of the
existence in the clinical history of data that, as it is irrelevant to the case being
investigated, is sensitive therefore it is advisable to separate it from the entirety of the
clinical history. Once the clinical history is found to be in the power of the judge, he
will be the guarantor of its custody and of preserving secrecy.
In non-legal procedures (in the private law sector), the legal authority automatically
accessing the full clinical history is not fully justified. In these cases, the doctor must
ask for a specification of the extremes of which are of legal interest. It must always be
considered that, in civil processes where private matters are settled, there may be
clinical history data that was obtained for another purpose and in another context,
which may be used to favour of one of the parties to the detriment of the other: for
example, if information regarding a mental illness or drug addiction contained in the
clinical history of a patient were to be used by his spouse in marriage separation
proceedings or in the ascription of custody over the children involved.
20. Third party access to the clinical history, for purposes that are not strictly care-related,
leading to the supervision and an improvement in the quality and efficiency of care
must be accepted, but in such a manner that the patient may not be directly
identified, except in cases in which the patient expressly authorises this (article 16 of
Law 41/2002 on Patient Autonomy and Rights and Obligations regarding Clinical
Information and Documentation). Administrative inspection procedures usually aim to
obtain certain information for care quality audits or for medical or pharmaceutical cost
control audits, in addition to enabling statistical studies of undeniable health and
social value. However, in all of these cases, the identification of the patient is not
strictly necessary, which is why, in the clinical history, the identification details of the
patient must be separated from all of the other data contained therein.
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21. When the clinical history is accessed by the patient’s family members or common-law
relations, various scenarios must be considered:
a. In the event that the patient is alive, he possesses full ability and he grants his
consent, the family members who have been duly authorised by the patient
will be able to access his clinical history with the same limitations as those
established for the patient himself.
b. In the event that the patient is alive but he has been declared incapable, or in
the event he has died, it must be considered that the right to privacy is not lost
in either of the two cited scenarios, meaning the doctor is ethically obliged to
preserve the secrecy of the clinical history and, in principle, third party access
to the clinical history must be restricted. In said scenarios, the requestors must
justify their access request and this must be medically and legally monitored.
c. In the event that a person prohibits anyone from accessing his clinical history
following his death, this prohibition will be respected as long as its veracity is
proven (article 18.4 of Law 41/2002 on Patient Autonomy and Rights and
Obligations regarding Clinical Information and Documentation). In the event
that a third party requests information contained in the clinical history,
justifying that in the clinical history there is data relevant to his health, strictly
the necessary information will be facilitated, but the third party may not have
direct access to the clinical history.
22. Whatever his age, every person has the right to his privacy being maintained before
third parties, including parents (Organic Law 1/96, of 15 January, on the Legal
Protection of the Minor). The minor may provide his doctor with information that
must be preserved.
However, parents are legally and morally responsible for their children, and civil and
penal laws demand they look after them, educate them and feed them (which
includes medical treatment). Therefore, parents are obliged to be informed of
everything that concerns their child, which means they have the right to access the
clinical history of their children, but not as though it were their own clinical history.
Article 9.3.c of Law 41/2002 on Patient Autonomy and Rights and Obligations
regarding Clinical Information and Documentation establishes sets adulthood for the
effects of making decisions regarding health at 16 years old. Between the ages of 12
and 16 years old, the minor may have certain autonomy, depending on his intellectual
86
and emotional maturity, but we understand that parents, as the legitimate
representatives and the people legally and morally responsible for the actions of the
minor, have the right to access the minor’s clinical history.
The doctor has the right to record in the clinical history every medical action carried
out on minors and the right not to submit to pressure or mutual understandings (cases
of abortion, sexually transmitted infections, the morning-after pill, drug addiction,
etc.).
V. Preservation of the clinical history
23. Law 41/2002, of 14 November, on Patient Autonomy and Rights and Obligations
regarding Clinical Information and Documentation constitutes the basic legal
regulations applicable throughout the State, with its development corresponding to
the autonomous communities that have very different fixed preservation periods for
the preservation of the clinical history. For example, Catalan law sets a period of
twenty years from the death of the patient while Galician and State law establish a
much shorter period of five years from the last time care was provided to the patient
or from the death of the patient, although the shorter period highlights a series of
documents that must be indefinitely preserved.
Although the Code of Ethics and Medical Deontology of the Organización Médica
Colegial de España (Spanish Collegiate Medical Association), like other European
deontological codes, does not establish the temporary extension of the duty of
doctors to preserve the clinical histories of their patients, they must be preserved for
at least 20 years from the death of the patient.
24. With the essential purpose of the clinical history being to facilitate patient care, it
must be preserved throughout the life of the patient. However, this is not merely due
to care reasons: it is also due to legal, historical, epidemiological and research factors
that oblige its preservation after death. The clinical history not only constitutes an
essential element in the defence of the patient’s legal rights, it also, occasionally, can
be a decisive element in the safeguarding of the legal rights of third parties (civil or
criminal complaints, inheritance claims, etc.). Clinical histories that may be considered
a piece of evidence in a crime must be preserved, as a minimum, until the prescription
period of this procedure has expired.
Clinical histories contain precious information for medical progress, which is why the
material contained within them must not be destroyed. As such, when the 20-year
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period following the patient’s death has been completed, clinical histories must be
preserved by disassociating the identity of the patient from the clinical data, therefore
the two interests at stake are reconciled: privacy and science.
25. When the doctor ceases individual private practise, clinical histories will be transferred
to the doctor who is taking over responsibility for the patients, with their prior consent
or, otherwise, to the corresponding medical association.
Madrid 24 and 25 November 2006
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The Ethics of the
Professional Relationship of
the Doctor with the
Pharmaceutical Industry
and Health Companies
89
Official Medical Associations), hosted on 12 May 2006, adopted the agreement to approve the
THE ETHICS OF THE PROFESSIONAL RELATIONSHIP OF THE DOCTOR
WITH THE PHARMACEUTICAL INDUSTRY AND HEALTH COMPANIES
1. Upon becoming a collegiate member, the doctor publicly accepts the deontological
commitment of providing human and scientific care to his patients (Code of Ethics and
Medical Deontology, article 18). This implies an ethic of prescription based on the
principles of freedom, as developed by the Comisión Central de Deontología (Central
Commission for Deontology) in its Declaration on the Doctor’s Freedom of Prescription
(1998), approved by the General Assembly and published in the Organización Médica
Colegial de España (Spanish Collegiate Medical Association)’s journal, no. 62 (February
1999). In this declaration, it is established that the freedom of prescription is linked to
professional responsibility, which implies the application of a therapeutic or diagnostic
measure must be preceded by a consideration of its scientific validity, its suitability to
a certain patient and its efficiency. The Declaration refers expressly to the economic
aspects of medical decisions: “The doctor must not forget that the money that must
be paid for prescriptions is not his, it is that of the patient or the institutions
responsible for them, and he must make rational use of it (…). This deontological duty
of prescribing with rationality and economic sense obliges the doctor to be fully
independent of restrictions that limit his freedom to do his best in each case, as well
as his economic best, for his patient or the person who is responsible for the costs."
2. The profound changes experienced by the health organisation in recent decades has
placed efficiency and the economic factor in a significant position regarding medical
decision making, which may be the subject of interference due to interests that do not
always coincide with those of the patient, who is the main subject of healthcare. As
such, at least two agents related to the doctor who decides on the prescription or
makes decisions with economic implications and who, in some circumstances, may be
unduly influenced by the interests of the service provider organisation (whether it is
public or private) and/or the health industry or company, may become involved in the
process.
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3. Therefore, the ethical problems or conflicts of interest for the doctor whose behaviour
must be guided by the principles of professional independence, loyalty to the patient
and transparency in society are laid out. The exemplary behaviour of the doctor is an
extremely relevant moral value in laying the foundations of trust in the clinical
relationship and social respect for the medical profession.
4. The Comisión Central de Deontología feels the need to offer collegiate members
some ethical and deontological criteria that may contribute, along with other agents
involved (health administration, pharmaceutical industry, health industry, scientific
societies, patient associations, care organisations) in the social deliberation of an
issue of great interest and with serious implications for the common good.
5. The relationship of the doctor with pharmaceutical and health companies must be
regulated by the principles and values that are characteristic of the medical
profession: scientific thoroughness and rationality, a spirit of cooperation, a sense of
serving patients and responsibility for society. This commitment of the doctor’s
professional loyalty must also inspire his relationships with health service providers,
whether they are public or private entities.
6. Pharmaceutical companies have legitimate commercial interests: the promotion of
their products via traditional information and advertising strategies that are ordinarily
accompanied by commercial attention. In Spain, a law (Royal Decree 1416/1994)
exists, detailing the limits and value of gifts and the hospitality that a doctor may
accept. In addition to what is established in the legal regulation, the doctor will strive
to maintain an attitude of elegance and seriousness in the face of commercial
attention and will prudently avoid any sign of advertising ostentation towards
patients.
7. It is acceptable, and even necessary, that the pharmaceutical industry organises and
finances scientific and training activities that are an essential and valuable element of
continued medical education. However, it must not be forgotten that this is a primary
ethical obligation of the doctor, for whose practical development the institution in
which the doctor practises his professional activity, whether exclusively or mainly, is
responsible.
8. Doctors who assume management responsibilities in scientific and medical training
activities that receive financing from private commercial organisations must
guarantee the independence of the content of the programmes they develop, and
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they will express with clarity and transparency the nature of the financing received.
The minutes of a scientific meeting dedicated to the promotional information of a
product or procedure will remain clearly defined. The doctor who participates in
these events as an expert must demand all such actions be declared in this way.
9. The information of the industry that facilitates the technology transfer of a new
health product or a new guideline with the potential for providing added value to the
quality of care is highly valuable. However, the practise of making medical
professionals the subject of promotional strategies that are merely repetitive and
which try to obtain the greatest number of publicity “hits” is reprehensible. The
doctor must analyse the time he invests in receiving information from the
pharmaceutical industry in accordance with efficiency criteria. He must maintain a
relationship based on usefulness, courtesy and professional respect with
representatives of the pharmaceutical and health industry.
10. Requesting or accepting remuneration in exchange for prescribing a medication or
using a health product is incompatible with medical deontology. This essential ethical
principle does not permit exceptions concealed in supposed research studies, for
example, pharmacovigilance, which leads to certain prescriptions being prescribed.
This criteria must also contribute to reflection – both that of the individual doctor and
that of medical groups – when establishing collaboration agreements with the health
industry in order to facilitate attendance at conferences, training activities or any
other kind of assistance.
11. Doctors with management responsibilities related to the acquisition of health
supplies have a deontological duty to exemplariness that surpasses the minimum
level required by legal guidelines, regarding doctors and staff at the institution as well
as users. Direct incentives of prescription – whether positive or negative – are also
contrary to ethics when they originate from the health centre’s managers, and are
especially reprehensible if promoted by professionals who are obliged to observe
medical deontology guidelines.
12. Cooperation between the medical profession and the health industry is necessary in
all stages of the development and use of medication or any other health material in
order to guarantee the safety of patients and the efficiency of treatments. The
doctor, who has the right to receive reasonable compensation from the industry for
his work as a researcher, consultant or teacher, also has the correlative right to
declare these links whenever appropriate and he will also complete the
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corresponding disclosure of interests, especially when publishing kinetic results.
When a doctor participates in a scientific research project promoted by a
pharmaceutical company, his participation must be conditional to having full freedom
over its publication, whether the results are favourable or not from the promoting
company’s perspective. The doctor who, in his role as expert, makes
recommendations in scientific mediums as well as the general media must make his
links, if any, with the industry clear.
13. Currently, the health administration in Spain dedicates scarce resources to the
continued training of doctors and it leaves a large part of its financing in the hands of
the pharmaceutical industry. In this situation, and bearing in mind the salaries
doctors in Spain receive, it is understandable that many doctors who, in order to
access the necessary updated professional training, turn to the help of the industry,
without which medical conferences would be impossible. For these reasons, and
while the situation remains unchanged, it is recommended that doctors seek advice
from the deontology commissions of medical associations before determining their
relationships with the pharmaceutical and health industry.
14. Some scientific organisations and medical institutions are recommending that their
members compile records of collaborations and voluntary disclosures of interests,
which would be exemplary behaviour related to promoting transparency regarding
essential ethical criteria in the relationships of doctors with the pharmaceutical and
health industry.
15. The Comisión Central de Deontología urges those responsible for medical training,
particularly that of medical students, to introduce in faculties, from the first years of
study, these ethical values.
Madrid, 16 May 2006
93
94
Declaration of the Comisión
Central de Deontología on
the Conscientious Objection
of the Doctor
95
Council of Official Medical Associations), hosted on 31 May 1997, adopted the agreement to
approve the declaration on “Conscientious Objection,” drawn up by the Comisión Central de
and Endorsement), which is transcribed below:
DECLARATION OF THE COMISIÓN CENTRAL DE DEONTOLOGÍA ON
THE CONSCIENTIOUS OBJECTION OF THE DOCTOR
INTRODUCTION
1. Lately, the conscientious objection of the doctor has become, both inside and outside of
the profession, the subject of debate. It is logical that, in the measure in which the ethical
pluralism of our society multiplies and becomes more explicit, the number of episodes in
which the doctor presents conscientious objection grows, meaning this results in
situations and conflicts between, on one hand, what laws prescribe, what health
managers order or what patients wish and, on the other hand, what doctors can do in all
conscience.
2. The Comisión Central de Deontología, Derecho Médico y Visado (Central Commission for
Deontology, Medical Rights and Endorsement) has been interrogated in recent times
about some aspects of the conscientious objection of the doctor, including its ethical
dignity, the actions to which it may be applied, and the extension and intensity of the
corporate protection for the objecting doctor.
3. There are not many deontological or legal points of reference regarding conscientious
objection. The current Code of Ethics and Medical Deontology does not avoid it but it does
not address it fully. None of the specific legal guidelines on matters that are open to
objection (current laws on abortion or assisted human reproduction, for example) include
any references to the conscientious objection of the doctor.
4. The Comisión Central de Deontología, Derecho Médico y Visado deems it appropriate to
offer this Declaration to complete and confirm deontological learning regarding
conscientious objection in order to guide the professional conduct of doctors and to
contribute to the social debate and to pave the way for fully comprehensive legal and
deontological regulation regarding the matter.
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ETHICAL, SOCIOLOGICAL AND LEGAL PRINCIPLES
1. The refusal of the doctor to perform, due to ethical or religious reasons, certain acts
that are ordered or tolerated by the appropriate authority is an action of great ethical
dignity when the reasons claimed by the doctor are serious, sincere and constant, and
when they refer to serious and essential issues. For the acts to which he
conscientiously objects, the objector feels a deep moral repugnance to the point that
subjecting himself to what is ordered or requested would equate to betraying his own
identity and conscience, and to staining his moral dignity. As article 18 of the
European Guide to Medical Ethics states, and as our Code of Ethics and Medical
Deontology repeats almost literally, “The doctor who, due to his personal convictions,
refuses to participate in reproduction processes or in cases of abortion, complies with
ethics.”
2. As an indication of civic maturity and moral and political progress, modern societies
accept the act of peaceful objection without the need for reprisals or exercising
discriminations against the objector, out of common respect for the principles of
ideological freedom and no discrimination against the fundamental rights of people,
which are consecrated in all constitutions. The tolerance of genuine conscientious
objection is something inherent to today’s society in which ethical pluralism is
accepted as a privileged reality for which other values, of high functionality and
efficiency but of inferior ethical dignity, must be sacrificed.
3. Conscientious objection is also a basic legal property. It exists not because it has been
recognised by the law: it is recognised by the law as it signifies and declares the civil
respect due to the moral identity of people. The ruling of the Constitutional Court of
11 April 1985 regarding a constitutional complaint put forward by the Organic Law
reforming article 417 of the previous Criminal Code declares, among other things, that
conscientious objection stands alone, which is to say, it does not need to be regulated
as it forms a part of the fundamental right to ideological and religious freedom
recognised by article 16.1 of the Spanish Constitution. The exercising of conscientious
objection, when adding Spanish constitutional jurisprudence, is directly applicable,
inasmuch as it addresses one of the fundamental rights.
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PRACTICAL ASPECTS
1. The exercising of conscientious objection may result in tense and potentially
controversial situations. When his objection is opposed, the doctor must always
demonstrate a calm and respectful attitude towards the patients, colleagues and
authorities whose convictions differ to his own, as stated in articles 27.1 and 35.3 of
the Code of Ethics and Medical Deontology. In such a unique situation, any violent
gesture is out of place.
2. Conscientious objection, which refers to the rejection of certain actions, must never
be considered a rejection of people. However, the objecting doctor, although
abstaining from practising the act objected to, is obliged, especially in emergency
situations, to provide any other preceding or subsequent medical attention to the
person who is the subject of the action objected to.
3. It would be ethically intolerable for a collegiate member to conscientiously object in
the institution in which he is a salaried employee but to practise the objected action
when he works independently. Such conduct would be an indication of moral duplicity
that would bring the medical profession into serious disrepute as it would reveal that
profit is the main motive for his behaviour. The Comisión Central de Deontología,
Derecho Médico y Visado is of the opinion that, in the legislation that regulates
professional conscientious objection, those who make spurious and improper use of
objection should be penalised with the maximum severity possible.
4. Considering the provision of assistance and advice of the medical association that
article 27.2 of the Code of Ethics and Medical Deontology highlights, the Comisión
Central de Deontología, Derecho Médico y Visado suggests the creation of a voluntary
and confidential procedure through which the objecting collegiate member
communicates his position to the president of the medical association in which he his
registered.
5. From an occupational perspective, conscientious objection may never imply an
advantage or disadvantage to the objecting doctor. It will not result in situations of
“punishment”, marginalisation or negative discrimination. The Organización Médica
Colegial de España (Spanish Collegiate Medical Association) must strongly oppose any
98
announcement of vacancies in public or private institutions that sees objecting doctors
suffer discrimination due to the action of conscientious objection. Regardless of what
the legal courts can determine concerning the illegality or unconstitutionality of said
announcements, the Organización Médical Colegial de España must intervene from a
deontological and statutory position to enforce the right of all collegiate members,
without distinction, to not be limited in their professional practise when they carry out
actions through a correct deontological channel (General Statutes of the Organización
Médica Colegial de España, article 42.e).
6. Likewise, conscientious objection may never imply, for he who objects, the
obtainment of occupational advantages. It would demean the ethical dignity of the
doctor who lodged conscientious objection to reduce his work load or to rule himself
out of inconvenient services. The objecting doctor will demonstrate the honesty of his
intention by enthusiastically fulfilling the task assigned to him to substitute the action
from which he has abstained due to conscientious objection.
7. It is undeniable that, in the future, when the ethical pluralism of society is
accentuated, the number of actions that the doctor may conscientiously object to will
increase. It is clear that other practises can be added to the classic objection to
abortion, assisted human reproduction actions (sterilisation, contraception, assisted
fertilisation, clinical embryology), such as the peaceful rejection of collaborating with
military medicine, to practising euthanasia, to collaborating on medically assisted
suicide, or to undertaking certain clinical protocols. Doctors may also refuse to
complete orders with an economic or administrative content that are imposed by the
health authority if they were to violate his conscience and freedom, or if they were to
cause prejudice or harm to patients.
8. However, the trivialisation of the subject objected to will never be legitimate. If, on
the one hand, honest conscience imposes with unnegotiable firmness the duty to
object when the objective severity of the matter requires it, on the other hand and
with the same firmness, it obliges the demonstration of extensive and respectful
tolerance of legitimate ideological and professional diversity.
Madrid, 3 June 1997
99
100
“The Internal Borders in
Professional Practise”
Deontological Considerations
regarding Limited Conflicts
Among and Between General
Practitioners and Specialist
Doctors
101
approve the following declaration, drawn up by the Comisión Central de Deontología,
Endorsement):
"The Internal Borders in Professional Practise" Deontological
Considerations regarding Limited Conflicts Among and Between
General Practitioners and Specialist Doctors
I. Introduction
In 1998, a Declaration on the internal borders in professional practise, prepared by the
Comisión Central de Deontología (Central Commission for Deontology) and offered by the
General Assembly of the Organización Médica Colegial de España (Spanish Collegiate Medical
Association, hereinafter OMC) to collegiate members and professional organisations was
published as an open work document.
The Declaration enjoyed a favourable response. It radically decreased the number of
reports of conflicts, which the Declaration aimed to remedy, and it was even cited as a
valuable teaching source in some legal cases. This does not mean that new conflicts – that
appear inevitable – arise occasionally, nor does it mean some doctors request the clear
definition of the scope of action in each medical speciality. These professionals, in addition to
circumscribing the area of their own activity, hope to establish a sort of exclusive right to
apply certain new techniques, act on specific areas of the body, and participate exclusively in
some functions or actions, such that their undertaking by other specialists would be
considered an interference contrary to ethical and legal guidelines.
These bordering conflicts present themselves with similar intensity in both private and
public medicine, favoured by the growing tendency to sub- or super-specialisation, which is,
at the same time, conditional to the cognitive and instrumental complexity of the different
specialities and the proliferation of technology that is more and more expensive,
sophisticated and short-lived. Some have branded these interferences of unqualified practise
thanks to a distorted interpretation of the legal and jurisprudential meaning of the term, such
that “the undertaking of acts proper of a profession by someone who lacks the academic
qualification issued or recognised in Spain” would become the undertaking of acts proper of a
speciality by someone who lacks the corresponding qualification. The result would be medical
specialities, according to hermeneutics, being elevated to the category of specific professions.
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On the other hand, it is obvious that the setting of rigid borders between medical
specialities would modify the dynamics of access to work posts and it would favour closed
positions in defence of economic interests and professional standing that, although justifiable,
may not be considered intangible. The problem with the internal limits of the medical
profession is not a merely doctrinal issue or an issue concerning the private interests of a
small number of collegiate members. It is, on the contrary, an issue that is capable of
provoking general conflicts of undoubted significance. Therefore, it seems pertinent to once
again propose, in light of the legislative and professional changes carried out since 1998, a
new version of the Declaration on the internal borders in professional practise.
II. Legal considerations
There are practically no guidelines in our state or autonomous region legislation that
highlight limits to the practise of the different medical specialities, and the few that may be
cited are so ambiguous that they may be considered non-existent. Not even an external
border that hermetically closes the practise of medical specialities to those who are not
doctors can be spoken about. Today, in public or private hospitals the practise of medicine in
a team implies that many professionals who are not doctors (biologists, chemists,
pharmacists, food technologists) participate in diverse stages of diagnostic or therapeutic
procedures. A brief review of the legislation related to the internal limits of the practise of
specialities enables the confirmation of the existing lack of definition.
There are no references to limits in General Health Law 14/1986, in Royal Order
127/1984 regulating the obtainment of the medical specialities qualification, or in the Ruling
of 25 April 1996 that develops said Royal Decree. Law 44/2993 on the Health Professions is
restricted, in this regard, to reiterating what is established in preceding legislation. With the
appearance of the Criminal Code of 1995, a legal debate was raised regarding the issue of
whether article 403.1, section two, could be interpreted as indicative of a crime of interprofessional interference as a doctrinal sector maintained. However, it is clear that the text of
this article must not be interpreted as “acts proper of a profession” and it must be interpreted
by doctrinal investigation and jurisprudence in order to acquire the necessary precision.
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Doctrinal debate continues to be the prey of contradictory conclusions; on the other
hand, jurisprudence, including constitutional jurisprudence, tends to believe there are no
supports in our legal system to attribute exclusivity over certain medical acts to specialists, or
to prohibit their practise to non-specialist doctors or those qualified in another speciality
which is closely related. Notwithstanding the aforementioned, cases of manifest abuse may
be legally sanctioned as crimes of fraud or as offences of professional imprudence, in the
event of interventions that demonstrate a lack of expertise, training or ability. On the other
hand, sanctioning administrative or collegiate activity is possible if prohibitions in terms of
specialities are infringed upon.
III. Professional considerations
Neither the General Statutes of the OMC nor the Code of Ethics and Medical
Deontology (CEMD) offer precise criteria about the matter. From a historical and professional
perspective, this legislative and deontological silence is logical. In effect, medical specialities
are not the result of a rational project of task distribution; on the contrary, they arose from an
historic evolution promoted by heterogeneous and casual reasons and forces that make a
rational and consistent delimitation of its respective particular areas impossible. The
subdivision of the work of specialists in public hospitals is not based on ethical criteria; it is
based on reasons of rationalisation and the internal distribution of the work. However, there
are some concepts that indirectly shed light on the problem:
As established in article 6.2.a of the Law on the Health Professions, the indication and
undertaking of activities aimed at the promotion and maintenance of health, the prevention
of illnesses and the diagnostic, treatment, therapy and rehabilitation of 105 patients, as well
as the judgements and prognosis of 105 processes that are the subject of care are the
responsibility of medical graduates. Therefore it can be confirmed that the diagnosis and
treatment of illnesses, the clinical judgement of patients’ situation, the interpretation of
diagnostic tests, and the adoption of measures to prevent illness and maintain health are
genuine medical acts that are exclusive to doctors. This is the border that separates medicine
from other health or paramedical professions.
Likewise, there is a border between the generic medical act and the specialised
medical act that would be determined by technical and regular reasons:
A medical act is considered specialised when, due to its complexity and possible risks,
it requires specific knowledge acquired during regulated and controlled training, or when it
implies the use of complex techniques or specific instrumentation, or if overall consensus that
this act corresponds to a certain speciality exists and that it must be addressed by specialists
only.
104
A medical act is considered exclusive to a speciality because it demonstrates the
aforementioned requirements not due to the mere fact that a guide for the speciality says so.
Medical acts may be performed by individuals who practise different specialities, as long as
they show that they have received said training during their period of education and training
and they are capable of doing so.
Paramedical acts are those that may be performed by members of professions that are
different to that of medicine (nurses, midwives, opticians, speech therapists, psychologists,
etc.) under the guidance or indication of a doctor. Although a graduate in medicine would be
able to perform acts proper of physicians of other professions due to the comprehensive
nature of the qualification (he who can do more can do less), it would not be ethical if he
were to do so, and much less if he were to practise these frequently and as regular activity.
Fixing artificial borders that establish a type of area reserved exclusively for certain specialists
for acting on set organic systems or exercising certain preventive, diagnostic or rehabilitative
practises, would be as ethically reprehensible as considering the non-existence of any limit
and that any person may publicly and regularly dedicate himself to practising as a specialist
without being one. Specialised acts must remain reserved for doctors who possess the
corresponding qualification, without prejudice to the fact any other person who is a graduate
in medicine and surgery may occasionally perform acts that, in other circumstances, remain
reserved for specialists.
The borders between care techniques that are commonly accepted exist, although
they are permeable. No doctor, if he possesses the necessary ability and knowledge, may be
prevented from applying them for the benefit of his patients, whether or not he has the title
of specialist. It should not be forgotten that, although the General Statutes of the OMC
include, among the rights of collegiate members, that of “not being limited to the practise of
the profession…” This right demands in correspondence that said practise “is done through a
correct deontological channel.”
Furthermore, it is a fundamental duty of doctors to maintain relationships of fraternity
between themselves and “treat each other with due deference, respect and loyalty,” a duty
that must only be ceded before the rights of the patient (article 31 of the CEMD). From a
deontological point of view, we must consider whether the practise of a speciality by
someone who lacks the corresponding qualification and has avoided the effort of obtaining it
could constitute a lack of loyalty, whose correction would correspond to the provincial
associations that, specifically, are assigned the task of “sanctioning the actions of collegiate
members who practise unfair competition."
The qualification of specialists confers the rights that are stated by law and implies a
legitimate assumption of preparation, knowledge and ability, but it does not in itself
indefinitely, automatically and perpetually imply the possession of the necessary ability. It
105
must not be forgotten that the specialist doctor is legally and ethically obliged to keep his
knowledge up to date, to not exceed his ability, and to not commit errors due to a lack of
preparation or excessive confidence (article 21 of the CEMD). As such, in the event that his
actions were to result in the harm of a patient, he will be obliged to justify his current ability:
possession of the qualification does not grant him immunity from negligence or a lack of good
judgement. Said requirement is more urgently necessary for the doctor who does not possess
the qualification of specialist and who will obviously encounter more difficulties to justify it.
IV. Conclusions
1. Although restricting professional action on a patient in favour of someone who
possesses the qualification of specialist does not legally or ethically exist, the Comisión
Central de Deontología deems that, from an ethical point of view, the decisive criteria
for responsible professional practise is to find oneself in possession of the necessary
ability to carry out the corresponding medical intervention. The Comisión also
considers that the usual and ordinary procedure for the acquisition and updating of
said ability is the following of the appropriate programmes of initial and continued
training for each speciality.
2. It is contrary to medical ethics and deontology that a doctor has the title of specialist
without being one. Likewise, it threatens the ethical and deontological regulations of
the doctor who, without being one, acts as a specialist in a regular manner that may
result in the misleading of patients regarding his professional qualification. This
behaviour is not justified by the fact that said action hopes to be concealed by
belonging to a team of specialists: the doctor is obliged to explicitly state his lack of
specialised qualification as a part of the stage of informing patients.
3. The main loyalty of the doctor is that which links him to his patient and “the health of
the patient must take precedence over any other interest” (article 4 of the CEMD). In
the event of actions that exceed his ability, the doctor must communicate this to the
patient and suggest turning to a colleague who is sufficiently trained in the matter.
4. The doctor who, without possessing specialist qualifications, or who is qualified in
another speciality, plans a certain intervention that may be considered typical of a
speciality that is different to the one in which he is qualified is obliged to consider
whether he really possess the knowledge, skills and experience necessary to carry out
the action and to assume responsibility for the consequences of his actions. In any
case, the doctor is obliged to communicate this to the patient prior to the act as a part
of the information the patient is due.
5. Additionally, he is obliged to justify the reasons for his decision before his association
106
and possibly before the courts and to demonstrate in a convincing manner that he
possesses the necessary ability to undertake it: no more, no less.
6. A doctor may never exceed the limits of his ability, outside of situations of extreme
emergency, without the immediate help of a colleague who is trained in the matter
(article 19 of the CEMD). This criteria is valid for the period of initial specialised
training and is also a permanent and universal deontological mandate.
7. The practise of medicine is based on scientific knowledge and technical ability, the
maintenance and updating of which is an individual duty of the doctor (article 21 of
the CEMD). As such, there is a close relationship between the frequency with which an
action is practised and the quality of care provided.
8. The doctor must have freedom of prescription as it is essential in providing, without
interferences, quality service to patients. However, said freedom implies a strong
sense of the responsibility that leads the doctor to recognise and accept the
consequences of his actions.
9. Every doctor is obliged to really understand the limits of his ability and he may not
ignore the risks he may run if, by acting in areas in which he has not acquired the
necessary experience, unfortunate consequences were to occur.
10. No one is obliged to do more than he can. If a doctor does not consider himself
qualified to undertake a certain intervention and he perceives that, due to emergency
reasons and other circumstances, the life or integrity of a patient is in serious and
imminent danger if said intervention is not carried out, he must, while requesting the
help of another colleague who is duly qualified, act without delay and to the full
extent of his ability.
Madrid, 28 May 2007
107
108
Hiring Doctors of Other
Nationalities with an
Imperfect Knowledge of
Spanish
109
approve the following declaration, drawn up by the Comisión Central de Deontología,
Endorsement) on the hiring of doctors of other nationalities with an imperfect knowledge of
Spanish, requested by the Colegio Oficial de Médicos de Soria:
REPORT
I. FACTS
Enquiry brought to the consideration of the Comisión Central de Deontología, Derecho
Medico y Visado (Central Commission for Deontology, Medical Rights and Endorsement) by
the President of the Colegio Oficial de Médicos de Soria regarding the following: “The
Autonomous Administration (Gerencia de Salud de Castilla y León-SACYL) is hiring foreign
doctors, mainly from Eastern European countries pertaining to the European Union, that
become members and practise medicine, occasionally with a total lack of knowledge of our
language, although they are usually provided with an interpreter who is a health worker
(nurse). The question is if the unrestricted professional practise of the doctor who does not
know the language of the patients to whom he must attend should be permitted and what
collateral considerations could be made (interference of the interpreter, restrictions and
limitations, collegiate acting guidelines, etc.”
II. BACKGROUND
The enquiry puts forward three questions: that of whether a person can practise medicine
without knowing the official language of the State (Spanish), what interference an interpreter
would have, and what collegiate actions may be launched.
The essential question is brought up by virtue of the dispositions set out in article 3 of the
Treaty Establishing the European Economic Community (Treaty of Rome), which establishes
that the suppression of obstacles to the free movement of peoples and services constitutes
one of the Community’s aims.
At the European Council that was hosted in Lisbon on 23 and 24 March 2000, the Comisión
adopted the criteria that the provision of services in any member state must be as simple as
in its own. At the Stockholm gathering in March 2001, under the motto “new European labour
markets open and accessible to all,” it acquired the commitment to establish clear, flexible
and precise guidelines to achieve these objectives. The response was Directive 2005/36/EC
110
passed by the Parliament on 07/09/2005, which establishes the requirements for professional
qualifications.
This directive says: The guarantee conferred by this Directive on persons having acquired their
professional qualifications in a Member State to have access to the same profession and
pursue it in another Member State with the same rights as nationals is without prejudice to
compliance by the migrant professional with any non-discriminatory conditions of pursuit
which might be laid down by the latter Member State, provided that these are objectively
justified and proportionate.
Therefore, it is evident that the rights doctors from different Member States may have to
practise in Spain will be conditional to the requirements, which must be justifiable, imposed
by the receiving State.
III. LEGAL AND DEONTOLOGICAL GROUNDS
1. Directive 2005/36/EC of 07/09/2005
Article 53. Knowledge of languages.
Persons benefiting from the recognition of professional qualifications shall have a
knowledge of the languages necessary for practising the profession in the host
Member State.
2. The Standing Committee of European Doctors, in 1977, when the free circulation of
doctors among the countries of the EEC was already a reality, adopted Agreement
CP1977/55 which, textually and laconically, states:
“Knowledge of the language of the host country constitutes, for the emigrating
doctor, a deontological duty for the purpose of guaranteeing the correct practise of
medicine”
3. Code of Ethics and Medical Deontology in Spain.
Chapter III: Relations between the doctor and his patients.
4. Basic Law on Patient Autonomy and Rights and Obligations regarding Clinical
Information and Documentation.
Chapters IV, on Informed Consent, and V, on the Clinical History.
111
5. Medicines Law (Ley 29/2006)
Article 77 on Prescription:
...3: “the medical prescription will be valid throughout the national territory and it
will be edited in the official language of the state and in the languages that are
equally recognised as official in autonomous communities.”
...5: The doctor will include the pertinent warnings for the pharmacist and the
patient.”
IV. CONSIDERATIONS
1. Communication is the essential element in the doctor-patient relationship. A full
medical act is not possible if there is not fluid communication between the doctor and
the patient, not only orally, but using gestures and interpreting silences and symbols.
It would even be desirable if a doctor were capable of understanding the localisms of
the place where he is practising. A lack of knowledge of the language results in an
impassable barrier between the patient and the doctor in the undertaking of a
relationship guided by emotions, feeling and information, which, to a certain extent,
may be replaced by an interpreter.
2. A series of administrative actions that require the knowledge of the language are
derived from the medical act: the writing of the clinical history, certificates, the
prescription, medical and legal documents, etc. All of these actions are patient rights
and duties for the doctor.
3. All national and international legislation is aimed at protecting patient rights, and
patients have the right to a freely chosen doctor who guarantees them efficient,
updated and safe care; who enables them to receive direct, understandable
information that is appropriate to their cultural and intellectual level; who guarantees
their confidentiality; who is capable of writing a clinical history as a guarantee for
future clinical actions; and who enables the maintenance of a relationship of mutual
trust, based on respect and understanding.
4. Directive 2005/36/EC, under whose protection this recruitment is occurring, clearly
demands, in article 53, sufficient knowledge of the language of the country welcoming
the professional who hopes to practise in another country.
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5. Therefore, we understand it is an ethical and legal requirement that the doctor knows
the language of his patients and it is a patient right to be able to communicate with
the doctor in a language of common knowledge.
6. The Consejo General de Colegios Oficiales de Médicos (General Council for Official
Medical Associations in Spain) has the power to set the criteria for collegiate
membership (article 2, section K of the current Statutes), as well as ensure
professional practise is suited to the interests of citizens. As such, it may dictate the
guidelines pertinent to guaranteeing that all collegiate members know Spanish.
7. A different fact is when, unintentionally and in the interest of a patient, a Spanish
doctor does makes use of an interpreter to attend to a foreign patient who is a
permanent or temporary resident in Spain.
8. A translator, even if he is a health worker, may not replace the paper that the doctor
issues in a medical act and the medical and legal documents that are derived from the
medical act. The doctor would not be able to accept the legal and ethical responsibility
that stems from a medical act influenced by a translator. The pharmacist would not be
able to fully exercise his task of dispensing a prescription either if the prescription has
not been made in the doctor’s own handwriting, but in that of a translator.
V. CONCLUSIONS
1. It is a deontological duty for practising medicine in Spain, both within the public health
sector and the private health sector, to possess sufficient knowledge of the Spanish
language, enabling the doctor to practise with security and guarantees. This also
enables the patient to communicate his symptoms and problems with the certainty
they are well understood and interpreted, and he will therefore receive the advice and
information that the medical act requires from the doctor.
2. It is suggested to the Consejo General de Colegios Oficiales de Médicos that it dictates
the guidelines that ensure all patients will be attended to by a doctor with a suitable
level of Spanish.
Madrid, 28 May 2007
113
114
Medical Ethics in Caring for
the Mature Minor
115
Council for Official Medical Asociations in Spain), hosted on 28 and 29 March 2008, adopted
the agreement to unanimously approve the following declaration, drawn up by the Comisión
Central de Deontología, Derecho Médico y Visado (Central Commission for Deontology,
Medical Law and Endorsement):
MEDICAL ETHICS IN CARING FOR THE MATURE MINOR
1. Fundamental concepts
1.1. We understand a ‘mature minor’ to be someone under 18 years old who has
reached the ability to understand, evaluate, express and order the scope of his
action so he must be granted autonomy to make decisions depending on his level
of maturity.
1.2. Evolutionary theories believe maturity and moral conscience are acquired
progressively and that they do not appear at a specific moment, with the period
between 12 and 15 years old being when values of justice, such as equality and
social commitments, are reached. However, some people need more time and
continue to develop, even after they have turned 18 years old.
1.3. Assessing the capacity of a minor is subjective. There are no valid and reliable
objective methods to evaluate this. Each patient should be assessed
independently and depending on the concrete action and its complexity.
1.4. When a minor is to be subjected to any medical act, the doctor, from his position
as guarantor, will assess the capacity of this minor to consent.
1.5. The doctor responsible must consider the capacity of the minor to judge and
evaluate the situation and to understand the medical act and its consequences.
Therefore, the minor must be capable of giving reasonable motives that support
his opinion and be capable of considering the risks and benefits of his decision.
1.6. The doctor will avoid committing the error of considering the minor who has a
different system of values to his own as immature or incapable. The maturity of
the minor may not be assessed based on his greater or lesser affinity to the
political, religious, moral or cultural values of the doctors.
116
1.7. Minors over 12 years old have the legal right to be listened to in advance of any
medical act. The opinion of the minor will be taken into consideration as a factor
that will be more determining depending on the degree of maturity.
1.8. Every minor patient that the doctor deems mature must receive information
regarding the diagnosis, prognosis and treatment options for his illness.
1.9. At no time must it be forgotten that the parents of the minor are those who are,
in principle, best prepared to evaluate his degree of maturity which is why, as long
as it is possible, they should be included in the assessment of the minor.
2. Legal aspects
2.1. In today’s world, minors enjoy greater standing in society. They are paid a lot of
attention in the media and there are more and more laws that safeguard their
rights and ensure their protection. Organic Law 1/1996 on the Legal Protection of
the Minor, as well as the Oviedo Agreement, gather these new tendencies of
granting the minor a new legal and social status, recognising him as the owner of
rights and a progressive capacity to exercise them.
2.2. Despite this, legislation regarding the consent of the mature minor is subject to
different interpretations, with rulings passed by different courts and provincial
audiences that are contradictory existing.
2.3. The Civil Code refers to this matter in articles 154 and 162:
Article 154: Children that are not emancipated are under the legal authority of
their biological parents. Parental rights and duties will always be exercised for the
benefit of the children (…). Parents, in the exercising of their legal authority, will
be able to seek the assistance of the authority.
Article 162: Parents who hold legal authority have legal representation for their
non-emancipated children who are minors (…). The actions related to rights of
personality or others that the child, in accordance with the laws and conditions of
maturity, may exercise himself are excluded.
2.4. Law 41/2002 on Patient Autonomy and Rights and Obligations regarding Clinical
Information and Documentation explicitly recognises the development of maturity
in minors:
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Article 5.2: The patient will be informed, even in cases of incapacity, in
a manner that is suited to his possibilities of understanding, with the
duty to inform his legal representative as well being fulfilled.
Article 9.3: Consent by representation will be granted when the minor
patient is not intellectually or morally capable of understanding the
scope of the intervention (…). The legal representative of the minor will
grant consent after having listened to the minor’s opinion if he is over
twelve years old. When minors are incapable, but emancipated or over
sixteen years old, consent by representation is not possible. However,
in the event of an action with a serious risk, according to the criteria of
the doctor, parents will be informed and their opinion will be
considered in the corresponding decision making process.
Article 9.4: Abortion, the practise of clinical trials and the practise of
human assisted reproduction techniques are governed by generally
stated guidelines regarding the age of majority and by special
application dispositions.
2.5. Therefore, it seems clear that Law 41/2002 specifies that, from the age of 12 years
old, the legal representative of the minor (normally the parents) will grant consent
after the opinion of the minor has been heard. However, this capacity to
represent remains subordinate to the decisions being in the interest of the minor.
2.6. Furthermore, Law 41/2002 establishes a new age of majority for health at 16
years old. From this age, parents may not make decisions related to the health of
their children unless they are incapable minors, in which case the legal authority
would have to intervene.
2.7. However, the same law, in order to grant consent in cases of abortion, the
practise of clinical trials and the practise of human assisted reproduction, the legal
age of majority is maintained at 18 years old.
2.8. Finally, Law 41/2002 indicates that between 16 and 18 years old and in the event
of an action of serious risk, according to the criteria of the doctor, parents must be
informed and their opinion will be considered.
2.9. The jurisprudence of the Constitutional Court and the Supreme Court was
constant and coinciding when highlighting that judges may order a treatment or
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hospitalisation to save the life of a patient against his wishes or against the wishes
of the legal representatives of a minor.
2.10. Cases of conscientious objection (recognised in article 16.1 of the Spanish
Constitution) that are proposed to the doctor in the care of the mature minor will
be resolved in exactly the same way in which they would if they involved an adult,
although the doctor must show absolute diligence to ensure the minor is attended
to.
3. Ethical aspects
3.1. The current Code of Ethics and Medical Deontology, in article 4.1, declares that
“respecting human life, the dignity of the individual and the healthcare of the
individual and the community are essential duties of the doctor” and, in article
4.2, it says “the health of the patient must come before any other interest.”
3.2. On the other hand, article 9.2 states that “the doctor must respect the patient’s
right to fully or partially reject a diagnostic test or treatment.” Furthermore, this
article authorises the doctor to suspend his relationship with a patient if he is
convinced that the patient does not show the necessary trust in him.
3.3. With regards to the mature minor, the Code leaves the issues rather open. In
article 10.6 it says “the opinion of the minor will be taken into consideration as a
factor that will be more determining depending on his age and degree of
maturity,” and with regards to emergency situations article 10.5 says “if the
patient is not in a condition to give his consent due to being under the legal age,
incapacitated or due to the urgency of the situation, and if it is impossible to
obtain the consent of his family or legal representative, the doctor must provide
the care his professional conscience dictates.”
3.4. The doctor may refuse, due to reasons of conscience, to carry out certain acts
(articles 9.3 and 26.1 of the Code and Declaration on Conscientious Objection of
the Organización Médica Colegial de España, 31 May 1997).
3.5. In order to exercise conscientious objection, it is recommended that this desire is
communicated to the doctor’s immediate superior in writing and signed, and sent
to the patient at the unit or service where his request may be attended. It is
advisable that the written document is also sent to the medical association for the
purpose of possible protection.
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3.6. The doctor who tends to a minor places himself in the position of guarantor and is
responsible for administering the principle of welfare when that of autonomy is
not applicable, whether due to temporary or permanent incapacity or due to the
patient being a minor. This position as guarantor requires him to verify that the
decisions made by legal representatives (parental rights and duties or custody) are
applied for the benefit of the minor.
4. Aspects related to the family of the minor
4.1. The concept of the mature minor does not imply the elimination of parental
intervention as guarantors of his health. Even in situations in which the minor is
considered mature by the doctor and therefore of sufficient capacity to decide,
parents and legal guardians must be informed of the medical act that will be
carried out and their consent must be sought.
4.2. If parents are not aware of the medical intervention, they will not be able to
ensure the information that the minor receives is accurate nor will they be able to
ask for a second opinion.
4.3. A problem is encountered when the right of mature minors to privacy,
confidentiality and autonomy comes into conflict with the right and duty of
parents or guardians to protect minors in their care.
4.4. If the doctor decides to perform any medical act on a mature minor who is under
16 years old without informing and obtaining the consent of parents, he will be
respecting the minor’s right to confidentiality but he will be violating the right of
those who are legally responsible for the minor to be informed. This conflict is
legal and ethical, and each professional must carefully consider the implications
and consequences. The same rule must be followed as that for similar cases of
conflicts of rights which follows the jurisprudence of the Constitutional Court:
exclusively and minimally violate the rights that are essential. There are very few
cases in which maintaining the confidentiality of a minor requires the parental
knowledge of the facts and decision making.
4.5. Another problem arises when there is a difference in opinions between the
mature minor and his parents or legal guardians regarding a specific diagnostic or
therapeutic intervention proposed by the doctor. In such an event, the doctor
must consider if there is a medically acceptable alternative that would satisfy the
wishes of the parents and the minor.
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4.6. If a reasonable alternative does not exist, the conflict persists and the mature
minor is under 16 years old, the doctor must pay special attention to the following
issues: a) when the medical intervention is necessary and urgent, the doctor must
prevent the parents’ opinions from generating risk or harm to the minor. He must
act and try to convince them and if the conflict persists, he must report it to the
public prosecutor’s office; b) when the intervention is not urgent but it requires a
mid-term intervention, the doctor must urge vigilance through the social services
if he observes a negative attitude of the parents regarding the minor’s illness; c)
any rejection of treatment by parents due to religious or cultural reasons that may
result in a risk to the minor must be made known to the legal authority.
4.7. In situations of conflict, the doctor must avoid trying to act as intermediary and
taking advantage of the situation to inform and educate appropriately.
4.8. In emergency situations the doctor’s opinion will prevail and he will make the
appropriate decisions to respect human life and the dignity of the person. If there
is time, he must consult the legal authority. The judges may order medical acts to
save the life of a patient.
4.9. The doctor has a legal obligation to always inform parents in cases of actions with
a serious risk to health, in cases of abortion and sterilisation, in the practise of
clinical trials and in the practise of human assisted reproduction, and he must
obtain their prior consent.
4.10. Obligatory hospitalisation must be done as long as there is a significant risk to
the minor or it is a life-threatening emergency. The legal authority must always be
made aware of this even if the parents give their consent.
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122
Minimum Times for Medical
Consultations
123
Council for Official Medical Associations in Spain), hosted on 13 September 2008, adopted the
agreement to unanimously approve the following declaration, drawn up by the Comisión
Medical Law and Endorsement):
Minimum Times for Medical Consultations
Background
1. In recent years, the progressive mass use of medical consultations has occurred in
Spain and this has translated into an easily demonstrable reduction in patient care
time, resulting in a serious risk to the quality of care and, consequently, to patient
health. This situation generates concern in both the medical profession and in society,
given that it is no longer a temporary shortfall but a chronic, refractory and growing
problem to the solutions that, up until now, have been applied.
2. The concern of collegiate members from different specialities can be perceived in
medical associations and they receive complaints about the difficulty in dedicating the
appropriate amount of time to patients. These demands for a solution to the lack of
time in consultations has resulted in a growing protest movement initially led by
primary care doctors – where situations of particular seriousness occur – but those
who work in specialised care are equally present.
Considerations
1.
It is well known that a fair amount of the main problems that affect medical
professionals today (stress, absenteeism, burnout syndrome, addictions, malpractice
complaints, assaults, etc.) are closely linked to the excessive pressure on care and the
conditions of precariousness in which many doctors carry out their work.
2.
The medical act is aimed at curing, alleviating, consoling and promoting the health of
our fellow man. Therefore, it is a professional act of assistance and service with a large
ethical significance, and it is also a legal act that is governed by legal guidelines in
which both parties have rights and obligations. For the fulfilment of these ethical and
legal requirements, possessing the necessary technical knowledge is not sufficient: a
suitable climate so the doctor-patient relationship may also be appropriate and
trusting is also required. The health authorities are responsible for providing the
necessary mechanisms to ensure doctors can work with security firstly and comfort
secondly with reasonable measures, among which the necessary consultation time is
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vital.
3.
If there is not sufficient time for the medical consultation, careful and attentive
healthcare cannot be provided, as required by professional ethics and legislation,
therefore reclaiming the necessary time to provide quality medical care is a
deontological duty and an unwavering professional right, as stipulated in the Code of
Ethics and Medical Deontology:
Article 18.1. All patients have the right to medical care that is human and
scientific in quality. The doctor has the responsibility of providing this,
whatever his type of professional practise, and promises to employ the
resources of medical science in a manner that is appropriate to his patient, in
accordance with medicine, current scientific knowledge and the possibilities
available to him.
Article 20.1. The doctor must have (…) the technical conditions that enable him
to act independently and with a guarantee of quality. If these conditions are
not fulfilled, he must inform the organisation that manages care and the
patient.
Article 20.2. Individually or through his organisations, the doctor must bring
the community’s attention to the deficiencies that prevent the correct practise
of his profession.
4.
We find ourselves faced with a complex and multifactorial problem where only a
correct diagnosis will enable efficient solutions to be reached. There are various
reasons that can be argued to explain the current mass use of care, including: a)
greater accessibility to significant and ever more numerous advancements in
healthcare; b) the increase in society’s expectations regarding health, which
sometimes becomes a consumerist attitude; c) greater longevity of the population; d)
an increase in the attending population; e) the practically fully free nature of care in
the public system.
5.
This continued excess of patients at consultations makes it necessary to establish
some limits with minimum conditions. In light of the difficulty in highlighting a fixed
time per consultation that may correlate with a guarantee of care quality, some
scientific organisations have carried out interesting studies that enable the
establishment of guiding recommendations regarding the time required depending on
the nature of the consultations for a certain speciality. On the other hand, we must
consider that the current deontological and legal framework grants the citizen some
rights related to the information and consent that require a certain amount of time is
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dedicated to the medical consultation that, a few decades ago, was not contemplated
and which currently can determine medical and legal liability.
6.
Balancing these aspects and defining a specific time for each medical act is complex
and it must be the professional criteria of the doctor that has the final practical
judgement on the consultation time, according to the individual needs of each patient.
However, when consultations are scheduled or when it is the patient himself who
requests medical care, as occurs in primary care consultations, schedules must have
limits. The figurative acceptance of at least “ten minutes” for primary care
consultations has symbolic importance but it does not stop being a good reference
point in signalling a “decent minimum.” Common sense indicates that under this time
a clinical interview and physical examination may not be performed in respectable
conditions. Therefore, it is not acceptable that care schedules are organised with the
assigning of a lesser amount of time. On the other hand, limits must be established for
the time that a doctor takes to carry out a care task without a rest period, although
this may vary depending on the characteristics of the activity performed. It should be
reported that these basic conditions, in both the dedication of time to each patient
and the prolonging of the consultation attended by just one doctor, are frequently
being seriously ignored, resulting in a risk to the safety of patients and doctors.
7.
In this context, when analysing the distribution of time for the activity of a doctor, it is
advisable to consider that, in order to maintain professional competency, clinical care
must be complemented with continued training. The role of the doctor does not mean
merely carrying out care tasks; the doctor must also have time in his work day to
acquire new knowledge and skills, as well as having time for teaching and research. In
this necessary equilibrium, we suffer a worrying imbalance due to the fact that the
excessive pressure the care task has overwhelmed many health centres, taking over
the time for training and research.
8.
It is logical that a certain tension exists between the demand for health services and
the inevitable limitation of the resources of any assurance system, whether it is public
or private, and this also includes the availability of time for professionals. The
distribution of resources is undoubtedly an ethical challenge in the management of
any health organisation where the optimisation of the measures available must be
balanced with the reasonable and justified increase of said measures. In this regard,
the Code of Ethics and Medical Deontology establishes the following:
Article 6.1. The doctor must be conscious of his professional duties to the
community and he is obliged to ensure maximum efficiency in his work and the
optimum performance of the measures that society makes available to him.
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Article 6.2. As the health system is the main instrument in society for care and
the promotion of health, doctors must ensure that it meets quality
requirements, care sufficiency and maintains ethical principles. Doctors are
obliged to report deficiencies that may affect correct patient care.
9.
The availability of the appropriate time for medical consultations is a necessary
element in guaranteeing trust, the pillar on which the human aspect of the doctorpatient relationship is based, which translates to more satisfactory medicine for the
patient and for the professional. However, it can also be a decisive factor in efficiency,
such that it helps to rationalise the use of diagnostic tests and medication
prescriptions, which also enables an increase in the safety of the patient and a
reduction in costs.
10. Due to these conditions of mass use, medical care is all too often provided in
conditions that do not fulfil the minimum occupational safety requirements, therefore
doctors are exposed to the anger of citizens when they consider their expectations,
which were sometimes promised, as let down, and this is accompanied by ever more
demanding legislation. One must consider that Law 41/2002, of 14 November, on
Patient Autonomy and Rights and Obligations regarding Clinical Information and
Documentation, like the demands established in medical deontology, encourages and
obliges the completion of a full clinical history and the appropriate informing of the
patient in order to obtain his consent.
These ethical and legal requirements are impossible to fulfil in the conditions in which
many doctors are obliged to work.
11. The complexity that health management entails must be recognised, however, the
time has come to firmly report the political indifference and conformism to the
organisational deficiencies. On the one hand, politicians boast of a high-efficiency
health system with a notable degree of user satisfaction, but that does not explain that
this comes at the expense of maintaining doctors in a situation of tension and
precariousness that has generated a worrying climate of unease and disillusionment in
the medical profession.
12. It is not difficult to see the problem is not merely quantitative: it is also, and above all,
qualitative. The efforts to increase resources without profound reform to
management are becoming banal and disappointing.
The reforms needed in management and which are recommended by experts, must
consider recovering the dignity of the medical profession. It is necessary to provide
doctors with greater autonomy in the organisation of their care activity, in accordance
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with the responsibility that entails, with this being closely linked to the availability of a
reasonable amount of time at the medical consultation.
Conclusions
1. The time needed for each medical act must be set by the professional criteria of the doctor
that impacts, ad casum, a practical judgement on the consultation time, bearing in mind
the individual needs of each patient and the obligation to ensuring optimum efficiency in
the doctor’s work as well as the optimal performance of the measures that society makes
available to him. However, in ordinary conditions, a “decent minimum” time must be
established as an impassable limit.
2. Satisfaction regarding Spanish health, which is in abundance in political declarations, must
cease and an analysis, which is credible and remains apart from electoral interests of the
actual situation, must be requested.
3. Medical associations must accept and protect the reports that, in the exercising of their
deontological responsibility, collegiate members make regarding the lack of time in
consultations, promoting the search for solutions that are mainly structural in
collaboration with scientific organisations, unions and all other agents involved in health.
4. It is recommended that provincial medical associations, with their autonomous councils
and the Consejo General de Colegios Oficiales de Médicos de España (General Council for
Official Medical Associations in Spain) as responsible institutions for society in their
respective scopes regarding the dignity of medical care, redouble their efforts in exercising
the responsibility that applies to them in the organisation of the profession in the face of
situations of mass care use that threaten the quality of care and have special repercussions
on society’s more vulnerable groups.
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Medical Values in Research
129
MEDICAL VALUES IN RESEARCH
Drawn up by the Commission for “Medical Values of the 21st Century” at the Organización
Médica Colegial de España.
Coordinator: Marcos Gómez Sancho
Rogelio Altisent, Jacinto Batiz, Luis Ciprés Casasnovas, Pablo Fernández Gutiérrez, José Antonio
Herranz Martínez, Manuel Pérez Martí, Joan Viñas
Introduction
Medical research is seeking answers to the questions that human health problems raise.
As such, research must always be present as an attitude in clinical practise, whatever
the speciality or care level, given that medicine permanently questions new issues in its
mission to serve humanity.
Therefore, it can be confirmed that research is a moral imperative for the community
that health professionals form and particularly for doctors.
Research models
Thanks to the biomedical model of research and the application of scientific and
technological advancements in the health sciences, undeniable developments have
resulted in enormous benefits for humanity. However, an exclusively biological focus
has proven to be insufficient in providing answers to the health needs of people. It is
important to consider that the interaction of biomedical and genetic factors with social
and psychological factors influence the causes and development of illnesses.
If we hope that research in the 21st century responds to the needs of more humanised
medicine, it is essential that the classic model of technical and experimental
predominance is complemented by two areas that are worth promoting.
Firstly, it is necessary to transfer the biopsychosocial model to the field of research. This
focus, which is centred on the most genuinely human dimension, is essential to
understanding the patient and his way of reacting to illness and suffering. As such, it is
necessary to promote qualitative research.
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Secondly, it is important to give greater impetus to research in epidemiology and public
health. The projects and investments that are undertaken to promote health must be
based on strict epidemiological data. It is advisable to consider that the communal
dimension may be decisive in providing solutions to certain health problems, taking into
consideration the impact, whether positive or negative, of the media.
Applications and priorities
The administration, research agencies and health organisations must guarantee that the
priorities in selecting projects are the authentic needs of health, paying special attention
to studies that, due to a lack of economic efficiency, do not receive financing from the
industry.
Establishing the priorities of medical research is a question of social ethics that has not
always been paid the appropriate attention. It should be remembered, as the World
Health Organisation has highlighted, that only 5% of global spending on health research
is related to the needs of developing countries who are the ones who suffer a
premature mortality rate of 93%.
Research regarding the causes of avoidable premature mortality is of significant
importance, for example: accidents (traffic, occupational, etc.), substance abuse,
unhealthy lifestyles (sedentary lifestyle, nourishment, etc.), suicide, etc.
Research on palliative care and pain treatment is still in its early stages and it must
continue to move forwards. The quality of life of people who suffer from chronic,
degenerative or terminal illnesses presents a challenge that will grow in the future.
Research will have to help to find better ways of treating the morbidity, disability and
dependence that the prolonging of life entails.
It is necessary to increase research on aspects of medical technology, which
encompasses information systems and the processing of data as well as diagnostic and
treatment measures, promoting the evaluation of technology and the results. Likewise,
the real effectiveness of health actions must be studied and not based purely on the
results of clinical trials that, by definition, modify the reality of daily care.
Furthermore, it is necessary to increase or intensify research on a series of problems
and areas of health that are the subject of concern or social expectation, such as
alternative medicines, rare diseases, preventive activities, mental health and health
education from childhood.
The ethics of research, in addition to respecting the principles of autonomy, welfare and
non-maleficence, require the fulfilment of efficiency and equality criteria. It is also
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relevant to consider the ethical aspects of the communication of knowledge, which
includes transparency and the disclosure of interests by authors and editors. The
negative results of a product must be published so they are known before the research
project is repeated with other patients.
Doctors must always regard the patient as his primary interest and research must be for
his benefit; when faced with a conflict of interests, the interests of the patient must
always prevail.
This document on medical research values is aimed at doctors and is also offered to all
health professionals, patient associations and agents in the world of biomedical
research (universities, research agencies, and the pharmaceutical industry) for
reflection.
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Ethics in Palliative Sedation
133
Council for Official Medical Associations in Spain), hosted on 21 February 2009, adopted the
agreement to approve the following declaration, drawn up by the Comisión Central de
Deontología, Derecho Médico y Visado (Central Commission for Deontology, Medical Law and
Endorsement):
ETHICS IN PALLIATIVE SEDATION
Introduction:
1.
In medicine, sedation is understood to be the administering of drugs to reduce the
anxiety, distress and, possibly, consciousness of the sick person.
In palliative medicine, sedation is understood to be the administering of appropriate
drugs to reduce the level of consciousness of the sick person when faced with a
refractory symptom to the treatments available.
2.
Patients who suffer from a terminal illness1, whether oncology-related or not,
sometimes present, in their final moments, a symptom that provokes unbearable
suffering that may be difficult or, occasionally, impossible to control.
3.
The borderline between what is palliative sedation and active euthanasia is found in
the main objectives of each. Sedation looks to achieve, with the minimum dosage of
drugs necessary, a level of consciousness in which the patient does not suffer
physically or emotionally, although this may indirectly shorten his life. In euthanasia,
immediate death is deliberately sought. The difference is clear if observed from the
perspective of medical ethics and deontology.
4.
Palliative sedation must be considered today as an appropriate treatment for sick
patients who, in the few days or hours that precede their death, are prisoner to
intolerable suffering that has not responded to set treatments.
1
Terminal stage is when an advanced-stage illness is found to be in an evolutionary and irreversible stage with
multiple symptoms, emotional impact, a loss of autonomy, with very scarce or no response ability to the specific
treatment and with a life prognosis limited to weeks or months, in a context of progressive fragility
134
5.
The need to decrease the consciousness of a patient in the hours preceding his death
has been and continues to be the subject of controversy in its clinical, ethical, legal
and religious aspects. Furthermore, those who do not understand the instructions and
technique of sedation, or who lack experience in palliative medicine, may confuse it
with a disguised form of euthanasia.
6.
The Comisión Central de Deontología (Central Commission for Deontology) deems it
necessary to offer criteria regarding the ethical aspects of palliative sedation for the
purpose of showing that if it is well recommended, well performed and authorised by
the patient or, if this is not possible, by the family, it constitutes good medical practise
in the appropriate care context.
Medical respect for the life of the terminally ill person
7.
Medical ethics and deontology establish respect for the life and dignity of all sick
patients, as well as possessing the due knowledge and competence to provide them
with professional and human care, as essential duties. These duties are of particular
relevance in the care of terminally ill people who must be offered the palliative
treatment that best contributes to alleviating suffering, while maintaining their
dignity, which includes rejecting useless or disproportionate treatments from those
that can only hope for a painful lengthening of their lives.
8.
Respecting the life and dignity of sick people implies attending to their wishes,
expressed verbally or in writing, which must always be recorded in the clinical history,
and reducing their pain and other symptoms with the necessary prudence and energy,
knowing that one is acting on a particularly vulnerable organism where recovery is no
longer possible.
9.
In a situation of terminal illness, medical ethics also implies the obligation of
accompanying and consoling, which are not delegable duties or duties of lesser
importance but medical acts that are highly relevant to quality care. Today,
therapeutic incompetence when confronted with terminal suffering, whether it is in
the form of unsuitable treatments due to insufficient or excessive dosages, or in the
form of abandonment, has no place in truly human medicine.
135
Ethical and human value of palliative sedation in agony 2
10.
In the past, before palliative medicine had been developed, sedation in agony may
have been ignored or the subject of abuse. Today, correct care implies resorting to
palliative sedation only when it is appropriately indicated, meaning after all the
treatments available for the alleviation of symptoms have failed.
Palliative sedation represents the last resource applicable to the sick person when
facing up to biological, emotional or existential symptoms after other therapeutic
resources have proven inefficient.
11.
Sedation is another therapeutic resource and therefore it is ethically neutral; what can
make sedation ethically acceptable or reprehensible is the purpose that is sought and
the circumstances in which it is applied. The teams who attend to terminally ill
patients need to have proven ability in the clinical and ethical aspects of palliative
medicine so sedation is appropriately suggested and applied. It may not become a
resource that, instead of serving the best interests of the terminally ill patient, serves
to reduce the effort of the doctor. Palliative sedation is a final resource: it will be
ethically acceptable when correct medical advice exists and all other therapeutic
resources have been exhausted.
12.
Sedation implies, for the terminally ill patient, a decision of deep, anthropological
meaning: that of refusing to consciously experience their own death. It also has
important psychological and emotional effects. Such a decision may not be taken
lightly by the care team: it must be the result of careful consideration and shared
reflection regarding the need to reduce the patient’s level of consciousness as a
therapeutic strategy.
Palliative sedation indications:
13.
Currently, the need to sedate a terminally ill patient obliges the doctor to evaluate the
treatments that the patient has received up to that point. Sedation is not legitimate
3
when faced with symptoms that are difficult to control but which have not
2
The agony stage is that which precedes death that occurs in a gradual manner, and in which an intense physical
deterioration, extreme weakness, a high frequency of cognitive and consciousness disorders, a difficulty ingesting,
and a life prognosis of hours or days exist.
3
The term ‘difficult’ may be applied to a symptom that, for its appropriate control, requires an intensive therapeutic
intervention, beyond usual measures, from a pharmacological, instrumental and/or psychological point of view.
136
4
demonstrated their refractory condition.
14.
The most frequent indications for palliative sedation are extreme situations of
delirium, dyspnoea, pain, massive haemorrhaging, anxiety or panic that have not
responded to treatments that have been suggested and applied correctly.
Sedation must not be used to alleviate the sorrow of family members or the work load
or distress of the people who are attending to the patient.
15.
It is necessary to inform the family that a terminally ill patient who is suitably sedated
does not suffer.
16.
Like any other treatment, a continued assessment of the level of sedation the patient
5
is in and needs must be carried out . In the clinical history and in the development
pages, the data related to an adjustment of the dosage of drugs used, the clinical
development of palliative sedation, and the basic care administered must be recorded
in detail.
17.
In order to assess, from an ethical and professional context, if palliative sedation of a
terminally ill patient is correct, consider the following criteria:
17.1. The application of palliative sedation requires the doctor to truly confirm the
following circumstances:
a. An intense and refractory symptomatology to the treatment exists.
b. The clinical data indicates a situation of imminent or approaching death.
c. The patient, or otherwise his family, has granted his/their appropriate
6
informed consent to palliative sedation.
4
The term ‘refractory’ may be applied to a symptom when it cannot be suitably controlled despite intense efforts to
find a tolerable treatment in a reasonable amount of time, without compromising the conscience of the patient.
5
This systematic assessment of the level of sedation may be carried out by using the Ramsay scale: Level I (Anxious
and agitated), Level II (cooperative, oriented and tranquil), Level III (Responsive to verbal commands), Level IV (Brisk
response to glabellar pressure or painful stimuli), Level V (Sluggish response to glabellar pressure or painful stimuli),
Level VI (No response).
6
Law 41/2002 on Patient Autonomy and Rights and Obligations Regarding Clinical Information and Documentation.
Art.9.3a
137
d. The patient has had the opportunity to satisfy his familial, social and
spiritual needs.
If he were to have doubts over the cited indication, the doctor responsible must
request the opinion of a colleague who is experienced in symptom control.
Furthermore, the doctor will make a record of this conclusion in the clinical
history, specifying the nature and intensity of the symptoms and the measures
that were employed to alleviate them (medication, dosage, and material and
human resources used) and he will inform the other members of the care team as
to his decisions.
17.2. It is a deontological duty to address palliative sedation decisively, even when
7
this treatment may result in, as a side effect, an earlier death.
17.3. The beginning of palliative sedation does not discharge the doctor from his
duty of continued care. Although sedation may last longer than initially
anticipated, basic and hygienic care required for the dignity of the dying patient
may not be suspended.
18.
Palliative sedation is not an exceptional treatment; the increase in people who require
palliative care actually constitutes a paradigm that must be present in teaching at
medical faculties, in programmes of continued training and in the conscience of all
doctors.
Madrid, 23 February 2009
7
Art. 27.1 of the Code of Ethics and Medical Deontology.
138
Badajoz Agreement on the
Teaching of Medical Ethics
and Deontology
139
Badajoz Agreement on the Teaching of Medical Ethics and
Deontology
Document of consensus between the Conferencia Nacional de Decanos de Facultades de
Medicina de España (National Conference of the Deans of Medical Faculties in Spain) and the
Comisiones de Deontología de los Colegios de Médicos de España (Deontology Commissions
of the Medical Associations of Spain).
1. With regards to the significance of the role of the doctor in our society and the existing
relationships between ethics and rights, it is essential to make public and study in
more detail the teaching of medical ethics and deontology as a basis for the conduct of
the doctor.
2. Neither medical ethics nor professional deontology may be considered a secondary
aspect to medicine: they are both an elements that characterises it.
3. Degree education: The Organización Médica Colegial de España (Spanish Collegiate
Medical Association, hereinafter OMC) and the academic authorities must collaborate
to ensure medical ethics and deontology are relevant parts of the teaching
programme for a degree in medicine. The contents of medical ethics and deontology
must be included in lesson plans in a medical degree, as stated in the white paper for
the qualification and Order ECI/332/2008, which establishes the requirements for the
verification of medical qualifications.
The contents of medical ethics and deontology must be taught in a linear process that
addresses initial years of the degree as well as the clinical stage of teaching.
Furthermore, these contents may be transversal to various teaching programmes. In
any case, the contents of medical ethics and deontology must be well defined in the
corresponding teaching guides. The contents of medical ethics and deontology must
include sufficient references to the Code of Ethics and Medical Deontology of the OMC
and other professional deontology codes, in addition to the basic principles of medical
ethics, bioethics and professional values. In this teaching, the collaboration of doctors
who, although they are not formally incorporated within the teaching framework of
faculties, may participate in teaching, especially if they have accredited experience or
are members of deontology commissions or other commissions of bioethics, must be
considered.
4. Continued training. The teaching of duties that the doctor must exercise in his
140
profession will be inspired by the Code of Ethics and Medical Deontology drawn up by
the OMC. This training and its permanent updating must be guaranteed. The basic and
essential objective of this teaching must focus on knowledge of the Code of Ethics and
Medical Deontology. The deontology commissions of medical associations must have a
role in managing and coordinating this teaching of doctors, by cooperating and
suggesting training initiatives through continued training courses, single subject
courses, seminars, etc. Likewise, these deontology commissions will carry out the task
of advising all collegiate member doctors. Deontology commissions must actively
participate in forums of debate with social agents (patient associations, associations
for the parents of students, consumer associations, the media, etc.) in order to divulge
deontological principles and establish a social debate regarding current issues.
Badajoz, 30 May 2009
141
142
Organización Médica
Colegial de España
Statement on Medical
Negligence
143
Organización Médica Colegial de España Statement on Medical
Negligence
We at the Organización Médica Colegial de España (Spanish Collegiate Medical Association,
hereinafter OMC) have been witnessing with concern and prudence the situation that
emerged following the death of baby Rayán and we were aware that sooner or later this
tragic event would turn into a public debate over so-called “medical negligence,” a concept
that is referred to when patient care problems arise, regardless of the accused professions
or institutions where the act takes place.
The trigger could be in some declarations from the President of the Consejo General de
Enfermería (General Council of Nursing), Máximo González Jurado, where he stated that if
the person involved had been a doctor, the impact the death of the young Moroccan boy
has resulted in would not have made the news. We are especially incensed as we
appreciated the initial good work: the moment the news broke, the highest representative
body for Spanish nurses acted, as one would expect of a professional collegiate
organisation, by simply backing the professional affected, on the one hand, and launching
the mechanisms to clarify the facts, applying, if necessary, the sanctioning abilities that our
States lend us.
This is not an attempt to enter into a futile debate as we at the OMC believe that these
declarations were formulated in a context of tension. Of course the words of Máximo
González were unfortunate and even more so when we know that we are fully working for
the safety of patients and the care practise. Although final responsibility for a professional
act falls on he who undertakes it, our actual work is developed in the scope of care teams
and in complex organisations where all the factors that influence our practise of care must
be assessed in the analysis of what happened.
This is not the ideal path for collective progress. Both professions are focussed on the
search for professional excellence and peaceful discussion that the mandate of the Law on
the Health Professions has given us. Comments such as these contribute little to this new
stage. Only patients and their better care keep the obligation of understanding alive.
17 July 2009
144
Statement from the
Organización Médica
Colegial de España on the
Death of the Footballer
Daniel Jarque
145
Statement from the Organización Médica Colegial de España on the Death of
the Footballer Daniel Jarque
In light of the many comments that are being expressed regarding the recent death of the
football player, Mr Daniel Jarque, the Consejo General de Colegios Oficiales de Médicos
(General Council for Official Medical Associations) deems it necessary to make the following
declarations:
1. Firstly, it regrets the loss of human life.
2. According to the information obtained by the media, the death did not occur while the
individual was exerting himself, meaning this is not a case of the sudden death of an
athlete.
3. This form of death is most common in patients who carry serious illnesses, although
this may be seen as an exception in some patients without evidence of a previously
known illness.
4. With the current data, it cannot be confirmed if the player suffered a heart attack or
another illness. As such, it is essential to wait for the results of the autopsy to know
the cause of death and offer a suitable diagnostic that avoids speculation.
5. The recent deaths of athletes has resulted in a significant increase in the awareness of
today’s society. In light of this, it is essential to remind society that:
o The risk of sudden death is extremely striking but infrequent.
o In high-level sport, medical and sports examinations are in line with the
recommendations of scientific organisations and the scientific and medical
options we have available today.
o With current knowledge, it is not possible to make the risk of sudden death
disappear in all cases, as it is impossible to diagnose in life some illnesses that
may cause it.
6. The practise of sport that is suited to each person is always and essentially beneficial
for the population. The risk of suffering an episode involving the sudden death of an
athlete is very low, especially in young people. Any athlete or person who participates
in physical exercise should, in the event he has doubts or it involves significant
overstraining, always follow the recommendations of his doctor. Likewise, it is
recommended the individual consults his doctor whenever he notices any physical
discomfort or pain when exercising.
12 August 2009
146
Exaggerated Anxiety and
Alarm are Being Created
regarding Swine Flu
147
Exaggerated Anxiety and Alarm are Being Created regarding Swine
Flu
The Organización Médica Colegial de España (Spanish Collegiate Medical Association,
hereinafter OMC) is of the opinion that the significance of this flu pandemic must not be
underestimated, but neither should it be exaggerated – as has been occurring up to now –
turning it into the exclusive focal point of health concern. 95% of cases will be mild and will
be resolved between three days and one week, like any other flu.
In light of the constant and varied information about swine flu that is being issued in all
forms of the media, the Consejo General de Colegios Oficiales de Médicos (General Council
for Official Medical Associations) would like to appeal to the population to help put this
problem into perspective.
The flu is a viral disease that usually appears during winter in the form of an epidemic
(seasonal epidemic) and it affects a large part of the population every year.
It is a mild illness whose most characteristic symptoms are a temperature, cough, nasal
secretion, headache, throat pain, muscular pain and fatigue, which result in the need for a
few days’ rest.
This year’s variant, which is known as swine flu, is more contagious than seasonal flu,
however, it is more benign and its mortality rate is lower. Identical prevention and
treatment measures to those used for regular flu should be used. In the majority of cases,
symptoms will be light and they will subside naturally, without the need for medication or
medical care.
The current situation
We also have the experience of what happened in countries with austral winter (winters
that coincide with summer in Spain) that did not have a vaccine and where this flu has left
1,796 people dead throughout this entire part of the world up to today, when any seasonal
flu that we experience every year leaves between 1,500 and 3,000 people dead in our
country alone. We can also look to what is happening in the United States of America where
a million cases have been detected and only 556 deaths have been recorded. It is clear that
the social perception this flu is enjoying does not correspond to its real level of impact,
which is inferior, in terms of deaths, to the seasonal flu of previous years and, of course, to
other deaths due to serious illnesses that must be tackled. Estimates indicate that 1 in every
148
3 European citizens will suffer from the new flu between 2009 and 2010, but we must add
that the majority of them will do so in a practically asymptomatic manner or with very
benign symptoms: in other words, 95% of cases will be mild and will resolve themselves
between three days and one week, like any other flu.
Pregnant women
The impact of the media on the effect of swine flu in pregnant women has set off unjustified
alarms.
Any pregnant woman is more vulnerable to any health problem. In the third trimester of
pregnancy, due to the abdominal pressure of the foetus which affects the cardio-respiratory
function of the pregnant women, any flu or respiratory process may often be more
complicated in pregnant women than in the rest of the population. However, this risk in
absolute values is minimal. Having said that, the probability of hospitalisation due to swine
flu for pregnant women is three in a million, while for women who are not pregnant it is one
in a million.
On the other hand, it is necessary to clarify that being pregnant does not increase the
probability of contracting swine flu. Swine flu does not cause miscarriages or deformities of
the foetus. Natural breastfeeding must be continued even if the woman has swine flu as,
according to normal hygiene guidelines, there is no problem posed to the breastfed baby.
Vaccination
Like with other flus, vaccination is a partially effective preventive measure. However,
although vaccinations are safe, they may also present adverse effects and, for this reason,
the vaccination must only be administered to risk groups that have been established by the
health authorities. The benefits of immunisation that are anticipated from a vaccine must
always be superior to the potential risks, especially for health individuals, of which the
majority would not fall ill and, if they were to, 95% of cases would present benign
symptomatology.
Treatment
Regarding treatments, antiviral drugs must only be used on people who are seriously ill and
patients with significant chronic illness. Of course, they are ineffective in healthy children
and adults. Some viruses develop resistance to antiviral drugs, limiting the efficiency of the
treatment, meaning medication must always be prescribed by the doctor.
149
Exaggerated alarm
Thanks to the data, we already know from the experience of winter in countries in the
southern hemisphere where the vaccine is available that swine flu is a benign illness with a
lower mortality rate than the flu we see every year. The difference is in the response: in
some countries it is with panic, fear and a lack of control; in others it is with normalcy, calm,
organisation and efficiency in appropriately treating only those cases where complications
arise.
The Consejo General de Colegios Oficiales de Médicos would like to inform the population in
a calm manner so we can all make good use of health resources. The behaviour that is
derived from exaggerated alarm would not only impede appropriate care for those who
really need it, it would also complicate the care due to other patients who, owing to other
significant illnesses, are attended to by our health services.
IN SUMMARY
1. Swine flu is very contagious but mild; milder than the flu we see every year (seasonal flu).
As such, there is no need to take great measures against swine flu: behaviour similar to
that of seasonal flu is required to ease the common symptoms such as general discomfort,
a lack of energy, temperature, throat pain and joint pain, among others. You should
consult your doctor when serious signs are added, such as difficulty breathing and
coughing up bloody sputum.
2. Antiviral drugs do not cure or prevent swine flu but they help to control serious cases. Like
all medication, they have side effects and their inappropriate use will facilitate the
appearance of resistance, meaning a decrease or disappearance in its efficiency against
the virus. They are not useful in cases of patients without complications, which is why
they must be reserved for treating serious case and for patients who, due to their
condition, the doctor deems it necessary.
3. The vaccination against swine flu is experimental and its safety and efficiency are not yet
known. The health authority must define the groups of the population that, due to their
characteristics, should be vaccinated.
4. The most serious consequences of past and current pandemics were instigated by
poverty, malnutrition, unsanitary living spaces, a lack of hygiene, a lack of antibiotics and
inefficient health systems. Past pandemics stopped causing a high mortality rate as soon
150
as antibiotics to treat the pneumonia that complicates the flu were introduced. These
pandemics never had a second “wave” of greater aggressiveness.
5. Citizens must be aware that, in addition to swine flu, the health services must attend to
thousands of acute and chronic illnesses that are usual, meaning it is advisable that the
activities of doctors and nurses are not saturated with patients suffering from mild cases
of swine flu.
6. This year and during the next epidemic of swine flu, it is likely that more cases of flu will
occur (as this strain is more contagious) but they will be of lesser severity and with a lower
mortality rate in all age groups.
7. “Spectacular” measures of care in health centres, hospitals, etc. give the false impression
that the contagiousness and severity can be reduced, but they are inefficient.
Consequently, we should all act normally and use common sense.
Remember that:
Swine flu is behaving in a more benign manner than the seasonal flu we have experienced in
recent years and simply as precautionary measures for this flu and any other infectious illness, it is
advisable that you:
•
•
•
•
•
•
•
•
Frequently wash your hands with soap and water.
Stay away from people who have a respiratory infection.
Do not share food, glasses or cutlery.
Always use disposable tissues to clean mucus and saliva.
Air the house and closed spaces and enable sunlight to enter them.
Keep communal spaces and objects that are commonly used clean, such as the kitchen,
bathroom, utensils, toys and telephone.
Maintain a healthy diet. Eat fruit and vegetables that are rich in vitamins A and C
(carrots, oranges, mandarins, limes, lemons, pineapple, etc.).
Keep hydrated by drinking frequently.
151
152
The Ethics of Responsibility in
Relation to Swine Flu
153
THE ETHICS OF RESPONSIBILITY IN RELATION TO SWINE FLU
The Consejo General de Colegios Oficiales de Médicos (General Council for Official Medical
Associations) would like to provide a series of considerations regarding the ethics of
precaution that legal elements provide and a call for calm in light of the climate of social and
professional concern that has arisen due to the epidemic of the new swine flu.
Preventive medicine is characterised by proactive intervention, in other words, acting before
a health problem appears or develops, but logically with the aim of achieving an improved
prognosis and benefit for the patient which must be supported by scientific trials that are as
detailed as those for any other cure treatment. Given that we act on healthy subjects in
preventive interventions, exactness in the efficiency trial and in the avoidance of adverse
effects is much more necessary.
This implies that preventive activities are also governed by the essential values of medicine.
For this reason, preventive medicine and proactive medicine are not synonymous concepts.
Proactive medicine does not automatically become preventive medicine and, to ensure it is
a responsible action, it is essential to consider the benefits and risks and suitably inform
patients and society. Preventive medicine is effective, safe, reasonable, merciful, fair and
prudent anticipation.
Preventive and proactive interventions currently enjoy great popularity, backed by the
known aphorism “better safe than sorry”; however, it does not always translate into positive
changes in the improvement of the future health of the individual or community.
For this purpose, we should highlight the existence of a climate of growing health
consumerism where preventive elements have an insured market, having generated a
phenomenon of tolerance in the strictness that should be required of advertising. The result
is a highly aggressive and growing commercial sector where large interests move and serious
harm can be generated as not everyone has the resources to draw up criteria that enables
them to separate the true information from the false (foodstuffs, early detection tests,
genetics testing, agreements, medication, vaccinations, etc.). In this area of the medical
profession special deontological responsibility that impedes the unjustified endorsement
of proposals that lack sufficient guarantees or which increase confusion, especially when
outside interests stand between those for the common good, must be accepted, whether by
the individual or the institution.
In this regard, prudence should be taken when presented with scenarios that imply a risk to
the population, such that information is offered in an understandable manner to the
citizenship and the way in which it can be interpreted must also be considered. This is
extremely relevant to avoiding collateral damage that could be prevented with a suitable
154
explanation. For example, due to the alarm generated because of the swine flu epidemic, a
worrying reduction in blood donations has occurred and this does not have a reasonable
justification. This endangers the lives of people who need blood transfusions. It must be
possible to organise special plans for addressing a potential emergency in a climate of calm,
which is convenient to ensuring they are beneficial.
In medicine, there is a series of general ethical principles that are applicable and required at
the preventive stage.
In accordance with the principle of “welfare”, a preventive intervention may not be
permitted if its beneficial effect for the health of the population has not been tested,
which implies that prevention may not have a status of immunity from criticism when
demonstrating its benefits. Remembering this is important as prevention has occasionally
been granted unjustified tolerance against the scientific requirements for any health
intervention.
In relation to swine flu, at times it seems as though mentioning the word “prevention” has a
thaumaturgical effect such that the responsibility of proof falls on those who raise questions
or reasonable doubts about some preventive proposals. In curative medicine, the
management of treatments with unproven efficiency is not permitted, however, sometimes
it is permitted as it may avoid the scientific exactitude of today’s medicine under the
framework of prevention.
The principle of “non-maleficence” means assessing the possible collateral effects that
preventive interventions may cause is necessary: false positives or negatives in early
detection, over-diagnosis or the potential side effects of any preventive pharmacological
treatment. This is particularly relevant when acting on the healthy population. The
consideration of any antiviral treatment for swine flu should also be grouped under this
principle, with a strict balance of the expected benefit and risk being achieved, bearing in
mind that the flu is considered a self-limited illness in a previously healthy individual.
In this regard, it would be particularly worrying if, due to political pressure or a defensive
attitude towards campaigns of public opinion, preventive interventions were carried out
without the appropriate safety guarantees, ignoring the principle of precaution that, due to
its scientific profile, every medical professional must consider. In fact, we should correctly
apply the principle of precaution: it is not more prudent to propose things that may or may
not be effective, but to recommend actions in which the benefits greatly exceed the risks
and costs inherent to any health intervention.
The bioethical principle of justice (in its scope of equality) applied to prevention requires
the prioritising of interventions in population groups that will enjoy the best return. A
155
certain activity would be inappropriately applied when the benefit is exceeded by the harm,
or when a waste of resources ends up affecting distributive justice. In other words, someone
with a high probability of benefit may not receive a resource because it has been spent on
an imprudent application in people with zero or very scarce possibilities of enjoying benefits.
Failures in health efficiency will affect equality sooner or later as resources will never be
unlimited.
Respecting the “autonomy” of citizens regarding preventive measures is an especially
delicate subject due to the difficulties that may arise in emergency situations. However, the
philosophy of informed consent continues to be applicable and, therefore, as long as it is
possible the patient must be suitably informed as to what is expected of a certain preventive
activity with regards to both the benefits and the risks. Likewise the risk that is accepted in
the event the preventive intervention is rejected must also be explained in an
understandable manner.
This is a professional challenge of the highest order, to the extent that it requires an effort
to update knowledge, resorting to reliable information sources that are also independent of
the health interests of our patients. Revealing information without alarmism and educating
with the information available is a duty and an art we cannot renounce out of loyalty to
citizens and society.
These are times for promoting social confidence in the health authority, doctors and other
health professionals, as well as the media, which is decisive in a free and democratic society.
We call upon all health services in autonomous communities to remain united by the ethics
of responsibility, which demand we assess the social consequences of the information and
measures to be adopted for the good of citizens and society as a whole.
156
Conscientious Objection is a
Right of all Citizens
157
Conscientious Objection is a Right of all Citizens
hereinafter OMC) would like to remind people that the Spanish Constitution and the Law on
the Health Professions (LOPS, using its Spanish acronym) support conscientious objection as
a right of all citizens and it demands a validation process for doctors and other health
professionals who wish to be protected by it.
If we are all equal in the eyes of the law, it is unthinkable to speak of “civil disobedience” in
the health sector but not in the legal sector when, for example, some magistrates resorted
to conscientious objection when faced with processing marriage records between people of
the same sex.
With regards to the option of minors under 16 years old having an abortion without parental
consent and the declarations made by the Justice Minister, Francisco Caamaño, in the sense
that “there can be no conscientious objection” of doctors, the Consejo General de Colegios
Oficiales de Médicos (General Council for Official Medical Associations) has declared his firm
rejection of this proposal and has reiterated that “nobody may be discriminated against
because of their principles.”
In this regard, the OMC would like to remind people that the legal and constitutional nature
of conscientious objection in health is a fundamental right that forms a part of the essential
content of the freedoms detailed in article 16 of the Constitution (ideological and religious
freedom), and, more specifically, the freedom of conscience as a common nucleus of both
freedoms. Therefore, this can be deduced from the analysis of the doctrine and the
positions of comparative law and, in particular, from the declaration of the Constitutional
Court contained in Ruling 161/1987 of 27 October. The LOPS refers to the ethical guidelines
of professional associations. Consequently, and even when governing laws in this matter are
scarce, conscientious objection is a constitutional right, like it is a right of the patient to
demand the best health service.
Conscientious objection in health may be considered a civil disobedience with difficulty, if
the Fiscal Council, in its Ruling on the Abortion Bill, approved by a majority the warning of its
possible unconstitutional nature.
On the other hand, if we are all equal in the eyes of the law, it is unthinkable to speak of
“civil disobedience” in the health sector but not in the legal sector when, for example, some
magistrates resorted to conscientious objections when faced with processing marriage
records between people of the same sex that are processed in their courts, subsequently
resolved by the Supreme Court or in other multiple cases.
158
It is evident that homogenous legislation regarding conscientious objection does not exist
and only reactive responses to specific cases that are dependent on legal laws, given that
our Constitution only contemplates conscientious objection in cases related to military
service and the media sector.
Therefore, the OMC has requested, with all due respect to the legal modifications in
progress, the “urgent” need for the new abortion bill to include, during its parliamentary
processing, the conscientious objection of health personnel who participate directly in such
acts, as is stipulated in almost all countries that have legalised abortion. In these countries,
conscientious objection is recognised as a specific right with clauses that prohibit the
discrimination of doctors who refuse, due to reasons of conscience, to participate in
abortive practises, especially if our future abortion law sees this action change from a
legalised crime in certain scenarios to a “right”: the “woman’s right to abortion.”
In short, in a “health benefit”, in a right that is exclusively limited by deadlines, and as a
medical act that is required and claimed, the doctor or health professional would remain in a
position of exception in any case, and not one of civil disobedience, as noted by the Ministry
of Justice.
The right to conscientious objection is a universal criteria of the medical profession. It is not
exclusive to doctors: patients may also exercise it (for example, when they oppose receiving
a certain treatment). Conflict may arise when the defence of certain principles harms the
legally established rights that one of the parties may claim. Therefore, conscientious
objection must be established in the general context of medicine, not only abortion,
guaranteeing the legal safety of everyone, including the unborn child in a case of abortion.
The Consejo General de Colegios Oficiales de Médicos, through its Comisión Central de
Deontología (Central Commission for Deontology), deems the deontological evaluation of
cases of authentic conscientious objection essential and, as such, it has proposed a
validation process for conscientious objection that, as recognised by the health authority,
would be subject to the renunciation of the legal obligation that doctors request from the
ruling that the medical association issues after analysing each case. This medical association
task would be perfectly coherent with the legal and constitutional concept that includes
conscientious objection.
17 August 2009
159
160
Criteria and Recommendations
for the Collegiate Recording of
Conscientious Objection
161
CRITERIA AND RECOMMENDATIONS FOR THE COLLEGIATE
RECORDING OF CONSCIENTIOUS OBJECTION
The Code of Ethics and Medical Deontology (article 26.2) and the recently approved
Declaration by the Comisión Central de Deontología (Central Commission for Deontology) on
Conscientious Objection states that the collegiate member doctor who proposes
conscientious objection (CO) to performing a certain professional practise may communicate
this stance to his association for the purpose of receiving advice and the necessary help to
guarantee this right.
The recording of this by the medical association aims to provide the doctor with
greater security and it may contribute to mediation in conflicts. It will be carried out via
communication to the general secretary of the provincial association and it will be gathered in
a confidential file where the name of the collegiate member and the health service to which
conscientious objection is raised will be noted.
The protection that the corporation guarantees the collegiate member who
undertakes CO advises the completion of a validation or ratification of the authenticity of the
CO communicated, which would be a task delegated to the Comisión de Deontología of the
corresponding provincial association.
This procedure may not be interpreted as a limiting of the constitutional right that
assists the collegiate member and it must be understood as counsel that enables the
observation and correction of cases in which CO may be requested in an inappropriate
manner: for example, the CO of generic palliative sedation has been incorrectly claimed.
The record will always be personal, voluntary and confidential. It must not be
confused with the creation of a list. In no way may “lists” of the doctors who exercise their
right to CO exist. It is extremely important to guarantee that the identity of the collegiate
member who conscientiously objects to a practise is treated in accordance with the doctrine
of the “necessary confidant,” which is to say it is known only by those required to manage the
record.
This means that when the Comisión Central de Deontología performs the “validation”
of the records, it will proceed on the grounds of objection such that it will usually not be
necessary to identify the doctor who has invoked CO. This confidentiality criteria is equally
applicable to the communication document the objecting doctor must submit to his
immediate superior in the institution where he practises his profession, such that only he who
162
needs to know the identity of the objecting doctor in order to reorganise the care activity will
have this information
The option of proceeding to record CO in the medical association before foreseeable
professional actions by speciality or by the service where a doctor exercises this right does
not imply a restriction of the right to CO in a sudden, unexpected situation, with it being
equally advisable in this case to immediately contact the Provincial Association.
163
164
Declaration of the
Organización Médica Colegial
on the Draft Bill on Sexual and
Reproductive Health (Abortion
Law)
165
DECLARATION OF THE ORGANIZACIÓN MÉDICA COLEGIAL ON THE
DRAFT BILL ON SEXUAL AND REPRODUCTIVE HEALTH (ABORTION
LAW)
Owing to the parliamentary debate on the Draft Bill on Abortion, the Organización Médica Colegial de
España (Spanish Collegiate Medical Association), conscious of its duties to citizens in general and
doctors in particular, publicly expresses its ethical commitments with regards to health that affect
some as beneficiaries of medical acts and others as necessary agents for their development, which is
why it presents the following considerations for public opinion:
1.
In accordance with the Code of Ethics and Medical Deontology, the medical profession is at
the service of human life.
2.
Collegiate member doctors will accept the laws passed by parliament but will always subject
them to the superior value of the freedom of conscience of each individual. Conscientious objection is
a fundamental and undeniable right. As such, the Organización Médica Colegial de España is pleased
to see the constitutional right to conscientious objection being reaffirmed for all professionals who
must participate as necessary co-operators in the practise of abortion.
3.
Doctors reject the use of the argument that the draft bill will provide them with greater legal
security when performing an abortion, given that this is not the case. Neither doctors nor the unborn
child will be better protected than they were with the previous law.
4.
This Draft Bill establishes a period of 14 weeks during which the woman will be free to have an
abortion. This limit is difficult to specify with the exactitude laws demand despite the technical means
currently available, which is why a subjective aspect has been introduced to advise the establishment
of prudence.
5.
Due to the aforementioned considerations, we believe it is necessary to state some minimum
guarantees:
•
Establish a system that prevents irregularities in medical reports that endorse the
fact the pregnancy implies a risk to the psychological or physical health of the
pregnant woman.
•
A protocol for informed consent must be created, offering the due guarantees of
validity and respect for the opinion and autonomy of the woman, with
information regarding the nature of the intervention and its risks.
•
A sufficient reflection period and information regarding the public and private
benefits to which the woman will have access in the event she decides to
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continue with the pregnancy should be given.
•
The technical and ethical commissions that establish the legality or illegality of
abortion must be re-established in public hospitals and any centre that performs
abortions. A decision that is as significant and which has such irreversible
consequences such as abortion may not be adopted by just one physician.
•
An abortion in minors between 16 years old and adulthood will never be
performed without their consent. We are pleased to see that the Organización
Médica Colegial de España’s suggestions regarding the convenience and
importance of informing parents or guardians are being considered, in order to
avoid the minor being deprived of their guidance, support and assistance.
167
168
Declaration of the
de España on Medical Action in
the Hunger Strike of Aminatu
Haidar
169
DECLARATION OF THE ORGANIZACIÓN MÉDICA COLEGIAL DE
ESPAÑA ON MEDICAL ACTION IN THE HUNGER STRIKE OF
AMINATU HAIDAR
There are legal guidelines in Spain that permits an individual’s wish to reject food to be
respected and, for the time being, the legal authority has interpreted these in this manner
for this case.
The problem that is raised from an ethical and deontological point of view admits some
considerations.
1. Medical deontology obliges respect for the free decisions of a competent person and,
therefore, a doctor may not force-feed a capable individual. However, he must inform
him of the risks to his health his decision entails. He must also assess up to what point it
is treated as a free decision that does not show evidence of manipulation or coercion.
2. If the doctor were to receive a legal order to feed the individual against his wishes, the
legal order must be fulfilled unless the doctor were to invoke conscientious objection, in
which case he will receive the protection of the collegiate organisation.
3. The Declaration of the World Medical Association on Care for Hunger Strikers analyses in
detail these situations and it prioritises respect for the wishes of the striker but it
highlights that this does not imply medically abandoning him. It underlines the
importance of privately conversing with the patient to clarify the reasons for his stance,
especially in political conflicts. Respecting his refusal to accept food may be reconciled
with hydration, which would grant a timeframe that always facilitates a negotiated
conclusion.
4. It is necessary to clarify that this is not a person in prison, nor is it a case of euthanasia or
a suicide attempt. Hunger strike as a means of peaceful protest is a different situation.
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Declaration on Conscientious
Objection
171
(General Council for Official Medical Associations), hosted on 24 October 2009, adopted the
Deontología, Derecho Médico y Visado (Central Commission for Deontology, Medical Law and
Endorsement). It also adopted the agreement to express its congratulations of the
aforementioned Comisión in its preparation and quick response:
DECLARATION ON CONSCIENTIOUS OBJECTION
Introduction
Conscientious objection (CO) in medicine arises from the conflict that occurs when
there is a clash between the moral duty of a professional in following the dictates of his
conscience and the legal duty that this professional must provide certain care. It is a very
topical issue and is considered in many circumstances to be due to the ever greater ethical
pluralism of society and the significant changes that have occurred in recent decades in the
way medicine is practised by the hand of genetic therapy and artificial fertilisation
treatments.
CO is not expressly regulated in the deontological code. It is mentioned in some
articles but it is addressed in an incomplete manner. As such, the Comisión Central de
Deontología (Central Commission for Deontology) has deemed it convenient to offer all
collegiate members this Declaration to complete deontological learning in this regard, guide
the conduct of doctors and transfer this information to society.
Conceptual delimitation and legal justification
1. CO is a form of resistance to the right that is conditioned by the impossibility of obeying a
law, regulation, ruling or order based on the moral convictions of a person. It is, in short,
the individual refusal to subject oneself, due to reasons of conscience, to a medical act
that, in principle, would be legally required. It differs to civil disobedience as it accepts the
reprimand that non-fulfilment of the guideline may result in for the offender. Civil
disobedience hopes to repeal this guideline and is usually a behaviour of a collective
nature or one with political arguments. Meanwhile, CO is an individual behaviour based
on moral or religious assumptions, in which the objector does not hope to repeal the
guideline with which he has not complied, but merely hopes to avoid reprimand for trying
to preserve the ruling of his conscience by failing to fulfil the guideline.
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2. Although CO is not expressly regulated except for in military service (article 30.2 of the
Spanish Constitution), there is jurisprudence related to its exercising by doctors,
essentially in cases of abortion. This jurisprudence is not unanimous and in some aspects
it is contradictory, which has caused no end of problems in terms of legal insecurity.
Ruling 53/1985 of the Constitutional Court (CC), in its legal basis (LB) 14 explains that the
right to CO “exists and may be exercised with independence of what is dictated in said
regulation,” given that “conscientious objection forms a part of the essential content of
the ideological and religious freedom recognised in article 16.1 of the Constitution.”
However, the same High Court, in LB 2 of its ruling 160/87 confirms that CO only is
legitimate in the measure in which article 30.2 of the Spanish Constitution establishes it as
“without this recognition, the right may not be exercised, not even under the protection
of ideological or conscientious freedom that, in itself, would not be sufficient to liberate
citizens from their constitutional or ‘sub-constitutional’ duties due to reasons of
conscience.” Ruling 161/87 from the same High Court is more emphatic in its LB 3:
“conscientious objection of a general nature, meaning the right to exemption from
fulfilling constitutional or legal duties against one’s own convictions, is not recognised and
has never been considered in our law or in any law, as it would signify the negation of the
concept of the State.” However, it admits that “what may happen is that it is admitted
exceptionally for a specific duty.” Despite this jurisprudence, today there is extensive
agreement in considering the right to CO as an autonomous, individual and fundamental
constitutional right; as a generic declaration of the individual’s right to freedom of
conscience, stated in article 16.1 of the Constitution. CO implies a specification of said
right when the subject comes into conflict with legal rights contrary to this specification.
Current deontological regulations
1. The World Medical Association’s Oslo Declaration on Abortion (Oslo 1970) and its
successive revisions up to the latest at Pilanesberg (South Africa) in 2006 establishes, in
point 6, “If the convictions of the doctor do not enable him to advise on or carry out an
abortion, he may withdraw, as long as he guarantees that a qualified colleague will
continue to provide medical care.”
2. The European Guide to Medical Ethics, in article 18, states “It is ethically acceptable for
the doctor, due to his personal convictions, to refuse to participate in reproduction
processes or in cases of pregnancy termination or abortions.”
3. The General Assembly of the Consejo General de Colegios Oficiales de Médicos (General
Council for Official Medical Associations), hosted on 31 May 1997, approved the Comisión
Central de Deontología’s Declaration on the Conscientious Objection of the Doctor, which,
in its ethical principles, states “The refusal of the doctor to perform, due to ethical or
religious reasons, certain acts that are ordered or tolerated by the authority is an action of
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great ethical dignity when the reasons claimed by the doctor are serious, sincere and
consistent, and they refer to serious and essential issues.”
4. The current Deontological Code mentions the right to CO in several articles:
Article 9.3: If the patient were to request a procedure that the doctor, due to scientific or
ethical reasons, deems unsuitable or unacceptable, the doctor, after duly informing the
patient, will remain exempt from acting.
Article 26.1: The doctor has the right to refuse, due to reasons of conscience, to
recommend a method of regulating and assisting reproduction, to performing sterilisation
or to terminating a pregnancy. He will immediately clarify his abstention and he will offer,
if applicable, the appropriate treatment for the problem regarding which he was
consulted. He will always respect the freedom of the people involved to seek the opinion
of other doctors. He must consider that the staff with whom he collaborates have their
own rights and duties.
Article 26.2: The doctor will be able to communicate to the medical association his stance
as conscientious objector for the purposes he deems appropriate, especially if said stance
results in administrative conflicts or conflicts in his professional practise. The association
will provide him with the necessary advice and assistance.
Practical considerations
1. The doctor can and should refuse to perform medical practises that go against the dictates
of his conscience. It is a moral duty and a just practise from a social perspective.
2. CO in medicine may never imply a discrimination of individuals. The doctor may refuse an
action as it signifies, for him, a serious moral problem, but never due to certain
characteristics of the patient such as age, race, ideology, religion or other similar aspects.
3. The objecting doctor will communicate his objection to the provision of the specific
service to the patient in a reasonable manner. In any case, he must direct the patient to
the professional or institution that can respond to the requested care need.
4. It is ethically reprehensible for a collegiate member to conscientiously object to a practise
in the institution in which he works as a salaried worker if he practises the action objected
to when he works independently. Such behaviour would be a sign of moral duplicity that
would result in the medical profession suffering a serious loss of prestige as it would
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reveal that profit is the main reason for this behaviour.
5. Exercising CO does not exempt the doctor from providing any other medical care,
especially in emergency situations, to the person who has caused his objection, even if
this emergency is related to the activity objected to.
6. The objecting doctor must communicate his stance to those responsible for the institution
where he works. He will also communicate it to his professional association.
7. CO may never signify discrimination of any kind against the doctor who exercises it. The
objecting doctor must never suffer from pressure when carrying out his tasks due to being
an objector. The objecting doctor will never obtain occupational advantages for his stance
and he will willingly accept other tasks that are assigned to him in the institution for which
he works.
8. In medicine today, there may be numerous causes of conscientious objection, including:
voluntary termination of a pregnancy, contraception, therapies with embryonic mother
cells, euthanasia, rejecting and demanding treatments, forced feeding of hunger strikers.
These situations can create serious conflicts of a moral nature and in daily practise, and
they must be addressed with reflection and calmness.
Madrid, 26 October 2009
175
176
“How to Give Bad News in the Correct Manner”
177
(General Council for Official Medical Associations), hosted on 25 September 2010,
adopted the agreement to approve the following declaration drawn up by the
Comisión Central de Deontología, Derecho Médico y Visado (Central Commission for
Deontology, Medical Law and Endorsement):
“HOW TO GIVE BAD NEWS IN THE CORRECT MANNER”
Introduction
Communication is an essential therapeutic tool in the doctor-patient
relationship, which contributes to respect for autonomy and promotes its participation
in care itself.
Article 10 of the Code of Ethics and Medical Deontology by the Organización
Médica Colegial de España (Spanish Collegiate Medical Association, hereinafter OMC),
which must be fulfilled by all collegiate member doctors, also mentions aspects
referring to informing the patient. It states:
“Patients have the right to receive information about their illness and the
doctor must make an effort to provide this information in a tactful and understandable
manner. The doctor will respect the patient’s decision to not be informed and will
communicate the extremes he deems appropriate to the family member or commonlaw relation who has been appointed for said purpose.”
Furthermore, informing the patient is a right recognised in enactment of the
General Health Law (1986) and ratified by the Basic Law on Patient Autonomy and
Rights and Obligations regarding Clinical Information and Documentation (2002), in
which article 4 establishes the following:
“Patients have the right to know, for the purpose of any action in the scope of
health, all the information available regarding the action, except in those scenarios
excepted by the law. Furthermore, every person has the right to see their desire to not
be informed respected.
(…)
Clinical information forms a part of all care actions and it will be truthful, it will
be communicated to the patient in an understandable manner that is appropriate to
his needs, and it will help in decision making in accordance with the patient’s own free
will.”
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However, when the illness does not have a curative treatment, and especially
when death is near, communication becomes more complex due to the emotional
impact that the act itself provokes in the patient, his family members and the doctor
himself.
In Latin culture it is frequent that, when faced with the serious situation of a
loved one, family members try to hide information from the patient with the
commendable intention of avoiding any added suffering.
With this document, it is hoped good medical practise will be promoted
through a series of recommendations regarding the appropriate way to communicate
bad news.
Recommendations for giving bad news in the correct manner
1. Giving bad news is a medical act and, at the same time, an art that must be
learned, but no strict formulas or protocols in this matter exist. Each doctor has
his own style.
2. The process of informing must be personalised. It is essential that the process is
adapted to the characteristics and values of the patient, bearing in mind family
members and the context in which communication takes place.
3. The doctor must understand well the illness, the personality of the patient and his
circumstances. It is necessary to offer information by balancing veracity and tact.
4. It is highly recommended to understand the information the patient has received
in advance and discover what he wishes to know. Hints may be obtained from the
patient himself as well as his family members and other professionals who have
attended to him previously.
5. The doctor should assess how much information the patient can come to terms
with and consider his psychological adjustment to the illness. When necessary, the
opinion of other professionals will be sought.
6. Information must be given when the patient requests it of the doctor, however, if
the doctor deems the moment unsuitable, he must say that the conversation will
be resumed as soon as possible.
7. When providing the patient with information, the establishment of a suitable
environment, free of urgency and interruptions, with the due privacy where the
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patient and his family members may freely express their emotions is
recommended.
8. During the communication process it is necessary to avoid technical terms that the
patient or his family members may not understand.
9. It is essential that silences and non-verbal communication are managed well.
During the conversation with the patient, pauses are recommended to enable the
patient to express himself.
10. Occasionally the circumstances of the patient mean it is recommended the doctor
is sparing with the information regarding diagnosis and prognosis so the patient
may progressively adapt to his new reality. Lying is never justifiable.
11. There are two exceptional situations in which the doctor is authorised to withhold
information: when the patient expresses his wish not to be informed or he does
not permit his family members to be informed, and when there is the wellfounded suspicion that the information may harm the patient due to reasons of
therapeutic need or a temporary nature. It is necessary to justify these exceptions
by noting them in the clinical history.
12. Although establishing prognoses on life expectancies is inevitable, they should not
be too restrictive.
13. A window of hope should be given, even to people who have a very limited life
expectancy.
14. The information the patient receives and his level of understanding must be
recorded in the clinical history, medical reports, etc.
15. Attention should be paid to the psychological reaction after receiving bad news. It
is possible that the patient will appear perplexed, hostile or uncertain, or he may
even forget or deny the information. The subsequent clarification of a term may
also be necessary.
16. The doctor-patient relationship is greatly strengthened when the information is
appropriate. It is recommended that the doctor maintains a close relationship
with the patient and underlines our commitment to assisting him and his family
members throughout the process.
17. We must remember that it is also necessary to be just as tactful when conveying
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information to family members.
18. If a family member or members advise against informing the patient we must
remember that it is our ethical and professional obligation is with the patient and
not the family. However, we are obliged to communicate with the family in order
to involve them in informing the patient.
19. The patient does not have to exclusively be informed of his diagnosis and
prognosis because the law obliges us, but because it is a professional, ethical and
human commitment of the doctor.
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182
Commitments and Demands of
the Profession in Light of the
Economic Crisis, the Crisis of
Values and the Governmental
Crisis in the National Health
System
183
COMMITMENTS AND DEMANDS OF THE PROFESSION IN LIGHT OF
THE ECONOMIC CRISIS, THE CRISIS OF VALUES AND THE
GOVERNMENTAL CRISIS IN THE NATIONAL HEALTH SYSTEM
CONTENTS
Commitments and demands of the profession in light of the economic crisis, the crisis of
values and the governmental crisis in the national health system.………………….……………….. p. 3
Institutional stance of the Organización Médica Colegial de España (OMC) regarding the
current economic, professional and social situation………………………………………………………... p. 6
We declare……………………………………………………………………………………………………………………….. p. 7
We offer…………………………………………………………………………………………………………………………… p. 9
We request……………………………………………………………………………………………………………………… p. 10
Epilogue…………………………………………………………………………………………………………………………… p. 12
Commitments and demands of the profession in light of the economic crisis, the crisis of
values and the governmental crisis in the national health system.
Ideas for a reflective speech on the medical profession
Where do we find ourselves? How have we reached this point?
The chronic financial and economic deficiency in the Sistema Nacional de Salud (National
Health System, hereinafter SNS) is the result of the annual increases in health costs above the
GDP of recent decades, the complex political, health and economic reality, the expansive
behaviour of driving cost factors, and the deep-rooted problems in the management of the
health services.
Health transfers, although they have had positive aspects in bringing decisions closer to
citizens, have introduced significant costs of political interference in our public health system.
The transfer of health competencies to the different autonomous communities (ACs) has
been made in the absence of effective planning and coordination instruments and
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mechanisms, which are a key premise to guaranteeing the governability of the system as a
whole and providing internal coherence and institutional stability to the process of
decentralisation.
In addition to all of these aspects, inequalities in the range of services, along with the lack of
coordination between ACs, resulting in real health borders arising due to the lack of common
policies and inter-territorial cooperation such as the lack of rigorous assessment for the
introduction of new technology (maintaining an inefficient division of the assessment
agencies) or the unequal treatment that is offered to citizens of other autonomous
communities in access to health services, not to mention aspects like computing systems that
are not interoperable between the different regional health services, individual health cards
that are only useful in each individual autonomous community and public health policies that
lack coordination, with the Ministry of Health having failed to assume its role as coordinator
and guarantor of equality.
Inefficient management and a functional lack of coordination has been the general norm in
the public policies of recent years. The medical profession has repeatedly denounced these
and has continually requested a large political agreement that would enable the introduction
of the reforms necessary to improve the processes of rationality and better administration of
the SNS and its institutions.
Even though it is true that every government in Europe is involved in a continued process of
reforming its health systems in order to address the challenges of sustainability in light of the
systemic crisis, as well as provide a response to needs in efficiency, quality, coverage and
equality, it is no less true that the political inability or lack of political desire of our leaders has
not enabled our country to reach the appropriate response and therefore achieve the
necessary agreements.
What are the consequences?
The global financial crisis has had a critical impact on the majority of developed economies,
particularly in the Eurozone.
In our country, and despite the structural reforms carried out (labour market, pensions,
savings banks, etc.), weak economic growth makes it difficult to achieve debt sustainability,
bringing added uncertainty to financial organisations in their necessary recapitalisation and
putting fiscal consolidation at risk.
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The undeniable need for the strict fulfilment of public deficit objectives has triggered hasty
and indiscriminate cuts on the health budget of certain ACs with unpredictable consequences.
We hope our political authorities, for reasons of credibility and trust, will demonstrate
improved transparency that will enable us to know, with complete veracity, the real
budgetary deficit of ACs, its structural component and distribution, in addition to spending
projections and anticipated fiscal adjustments, so we all feel jointly responsible for the
sustainability of a priority social function such as public health.
Despite public health spending practically doubling in the last decade, the health indicators
that really contribute to the state of health or illness of individuals and populations has not
improved noticeably in our country.
Although we know smoking, obesity, alcohol, a sedentary lifestyle, drug addictions and other
factors are the direct cause of the majority of morbidity and mortality mainly in the
developed world, all of these factors are the consequence of cultural, social, economic,
occupational, educational and environmental deficits. The World Health Organisation (WHO)
published, in 2009, the final report of the Commission on Social Determinants of Health,
championing a series of measures against these factors, which will enable health equality to
be achieved, offsetting the inequalities in a generation*.
* (http://whqlibdoc.who.int/publications/2009/9789243563701_spa.pdf)
We cannot forget, through our medical professionalism, the effects of the crisis on the
employment rate that affects, in particular, our young people who cannot find a suitable work
framework that affords them the opportunity of worthy and continued personal and
professional development. It would not be strange to find this life frustration could manifest
itself in irresponsible social conduct and attitudes that are removed from the collective or
common interest, which in turn result in new support and healthcare demands.
Due to his professional and social ethics, the doctor is obliged to participate in resolving the
consequences provoked by the crisis in our health institutions and, in particular, managing
(which is the crude reality) and responding to the health needs of citizens, especially the
sickest, most disadvantaged, weakest and least informed.
Every day political and economic pressures proliferate and become more evident as they try
to intervene and freely condition the doctor’s exercising of responsibility and practise.
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The most deep-seated health problems naturally enter subsequent legislation or false,
ambiguous or defensive regulations are established but are impossible to put into practise.
At the same time, a part of society settles into a moral relativism, the main symptom of which
is passiveness, hoping that “something happens” or that “someone does something” which
only favours social disaffection, irrationality, civil decapitalisation and a failure of the ability to
learn from previous errors as joint responsibility for these errors is not recognised or is
diluted.
The doctor feels, in all conscience, torn; on the one hand, he is guided by his ethical and
deontological obligations, the application of scientific and patient needs; on the other hand,
he is affected by cuts, imposed limitations, interferences and demands set by authorities,
managers and society itself. All of this occurs in a context of uncertainty where there is a lack
of an integral explanatory model to understand where we find ourselves, while there is also a
health policy of institutional design with a future vision that generates trust and security and
in which we feel as though we take part and for which we feel responsibility.
We must find answers in medical professionalism to these ethical dilemmas that reinforce our
social legitimacy, legal security, just recognition, competent self-management ability and
institutional participation.
These are unavoidable demands that we are experiencing today in light of the current critical
status of health. These demands question us from our public and social conscience as we will
preserve the essential values of our professional identity, we will be able to revise and adapt
practise and relationship models in order to provide a response to the new needs,
expectations and demands of society and, in short, to project joint responsibility for a shared
commitment to modernisation, sustainability and internal cohesion of the SNS.
Institutional stance of the Organización Médica Colegial de España regarding
the current economic, professional and social situation.
hereinafter OMC), as the collegiate organisation for the medical profession, is established in
the scope of democratic representation and public liberties to manage in a preferential
manner, and from principles of good institutional government, the processes for regulating
and controlling professional practises, sharing this function of public guarantee with the
power it is granted to its administrations by the State.
187
The OMC is an ethical and democratic space for professional and managerial freedoms of
doctors, constituted as an instrument of professional government and a guarantee of
essential public rights. Its mission is focussed on driving and governing good professional
practises at the service of the patient as well as the promotion of health in people and the
population. This responsibility is made effective through a process of creating different
integrated health and social competencies in which medical professionalism is considered.
These actions in the OMC mission require a sustainable and fair SNS that is well governed at
an institutional level and managed with efficiency and technical rationality.
New medical professionalism implies defending, above any other circumstance, the
commitment to patient needs and medical values based on professional ability, integrity,
morality, altruism, confidentiality, secrecy, respect for privacy and respect for life in any of its
states, as bases of trust and reliability between doctor and patient. These essential values are
complemented by the promotion of a preferential social good, as is health, and the joint
responsibility of everyone involved in the SNS, the central institution of the welfare state that
enables a fair and professionally competent response to the health needs of the population.
The medical deontology code establishes, with precision, and develops all of these ethical
commitments that form a part of the implicit social contract between medical associations
and society itself, and they represent the basis of its legitimisation.
In order to consolidate and offer future generations this fundamental service of the welfare
state, it is essential that doctors renew their commitments by backing the structural changes
needed to maintain the high level of quality reached in public health services and to make
them sustainable. It is necessary to become engaged in and drive the processes of change as a
response to great social transformations, mainly fulfilling two essential conditions: welfare,
equality and efficiency are promoted as preferential social principles; and doing this via the
ethical and exemplary restoration of the administration of public assets. It demands that we
address the complexity of the economic crisis and its impact on health services from the
perspective of public and social ethics, while also offering proposals to consolidate and
modernise a fair and quality health system.
The authority must recognise the central role of the medical profession in reorienting and
guiding its own professional and social progress, in addition to the organisation and
management of the health services as without effective and rational development of the
essential values of our profession, it is not possible to achieve a modern, efficient and
humanist health system.
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Hence the General Assembly of the OMC wishes to declare:
1. The SNS in general and the health services in particular form a part of a strategic
production sector of the economy of knowledge, generating wealth, welfare, scientific
innovation and qualified employment, based on substantial principles of social
equality and solidarity as the collective heritage and undeniable right of all Spaniards.
2. Not only has the SNS been sustainable up to now, it has also experienced growth,
development and consolidation in recent decades unlike any other social public
institution. The issue is if it will be able to continue being sustainable with the
restrictive financial conditions and structural adjustments that are being imposed
today. Our collegiate institution wishes to declare its deep concern for the
consequences and effects of indiscriminate cuts to the public health sector as a result
of the persistent financial shortfall of the SNS.
3. The economic, financial and debt crisis has resulted in a critical situation that urgently
requires solutions from the political and economic leaders in our country. We believe
that the health model of perpetual immobility, which is refractory to all kinds of
structural reforms that are necessary and characterised by its persistent recourse to
the rule of rescue in its economic management, is not the most suitable model for
addressing the challenge of sustainability, organic growth and social legitimation.
4. It is essential that the political and health authority offers an institutional stance and a
believable, explanatory reference that generates trust and certainty regarding the
present and future of the SNS.
5. On 21 July 2010 we presented, at a formal meeting of the Congress of Deputies, and
delivered, to the Speaker of the House and the spokespersons of the different
parliamentary groups, a declaration in which we clearly state that the first obligation
of doctors is to preserve and defend the interests of patients above their own, and to
orient all their decisions for the common good.
6. Given the above and due to its scope of responsibility, the medical profession cannot
accept cuts in health financing that result in losses of quality in patient care when it is
also possible that their effects may impact on the poorest, weakest, oldest, most
disadvantaged and most vulnerable individuals in particular. The doctor must ethically
189
reject these indiscriminate and irrational changes, report their consequences and
rebel peacefully against them.
7. Doctors must worry about the “origin of causes” in health and in illnesses and, in
particular, how social inequalities influence the health status of people and
populations. At the same time, health is a fundamental social determinant that affects
other factors, such as the level of economic progress and the welfare of people.
Doctors cannot accept cuts to the prevention and promotion of health or health
education as we understand that this will result in mid- or long-term consequences for
individual and collective health.
8. We understand through public rationality that political, territorial and other public
structures exist and, due to social efficiency and collective needs, they must be
preferential areas when applying cuts for the containment of public spending.
9. Beyond the initial political responsibilities and ethically reprehensible behaviours of
the financial markets and the functioning of the economy, the solvency crisis that
affects the SNS once again requires the deontological commitment of doctors and
their proactive and socially exemplary vital attitude to help in the practise of their
professional abilities to strengthen essential services and institutions, cooperate on
reforms that are needed to consolidate the health legacy for future generations, and
contribute to guaranteeing the universal right to health that our constitution
considers.
10. The idea is not easy to present before the medical profession, following so many years
of inattention and a lack of recognition by the different governments of the system,
especially for primary care doctors. As such, it is necessary to commence a moral
regeneration that fosters the survival of the system. The economic crisis complicates
this whole process, but it makes it more necessary than ever, which is why the ethical
and deontological principles of justice, consecrated in article, 7 (sections 4 and 5) of
the Deontological Code, must be considered, without delay, as an intrinsic value of our
own social culture of responsibility, developing in full this ethical virtue in everyday
professional practise. Introducing economic sense in professional decisions has always
been relevant but today it is especially necessary and ethically obligatory as we know
that social efficiency is an undeniable value in the use of public resources.
11. We believe it is unfair to continue reducing the payroll of health professionals when an
analysis compared with other health systems situates our remuneration standards at
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the lowest level of the rankings for Eurozone countries. Furthermore, in the last 25
years, the remuneration capital of health personnel has lost more than 13 percentage
points in the economic-budgetary structure of the public health system, an assigned
adjustment that is unprecedented in socially developed Europe.
12. Doctors have always been willing to participate in processes of rationality that apply to
them but with rigorous evaluation, consideration and proportionality. As such, doctors
feel jointly responsible, due to their professional credentials, for proactively
contributing and participating in improving the dimensions of efficiency and quality in
our health system.
Due to certain values society recognises and with which it identifies,
WE OFFER:
Vocation for service, prioritising ethical principles, a competent and moral attitude in care
practises, promotion of the common good, a guarantee of professional credentialism,
scientific humanism and adhesion to the constitutional right to the protection of health.
Strengthening of the role of citizen health, for which we offer information, participation,
transparency, autonomy, representation, the sharing of decisions that affect universal values
that justify public health services, and a response to the needs of the different groups that
constitute our current society.
Shared social responsibility in the good administration of health institutions themselves and in
defence of the values that legitimise the public health services.
Guaranteeing care quality through medical progress and scientific advancement, along with
the defence of ethical principles where the construction of a more prosperous, just and
supportive society is laid out.
Rationalising of services, use of health resources and services in terms of cost effectiveness,
while showing continued commitment to the quick and efficient distribution of advancements
in the biomedical sciences.
Prioritising of actions on epidemiological and population bases, meaning in terms of needs
and results in health.
Improving of the essential competencies of public services (intellectual, technology and social
capital).
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THEREFORE WE REQUEST:
The political power responds to its obligation to society and leads a dynamic and transforming
project that guarantees sufficiency, sustainability, governability, cohesion and equality as
basic fundaments in the social legitimation of the SNS and the welfare state. It should not
postpone further the political commitment of proposing a final and sufficient financing model
that guarantees the sustainability of the SNS.
A social and political agreement to revitalise the SNS and guarantee its sustainability based on
criteria of social cohesion and uniqueness through the integration of its functions, activities
and essential competencies linked to the legal scope of public ownership, as well as the
promotion of participatory medical professionalism and joint responsibility in the
governability and co-management of common health heritage.
The establishment of a model of good health management, promoting the professionalization
of management in the health services and adopting criteria of transparency, merit and
capacity. All of this should be done through the development of new managerial and
administrative practises with the assessment of organisational and professional competencies
for the improved management of operational knowledge. This must be comprised of central
action points in every process of promotion and professional recognition in health institutions
and centres.
The creation of a health information system for the SNS that is interoperable with all the
autonomous health systems with decentralised clinical history databases with restricted
access, in addition to professional help information of a general, specific and selective nature.
This will facilitate the conditions required to drive decentralisation processes to services and
develop clinical management.
The redefining of the remuneration model for professionals, with a part of this system being
linked to care results and quality.
The instigation of an effective change to the care and professional model. The main profile of
the patient we attend to is a chronic, fragile and poly-medicated patient. This evidence
requires an organisational redesign of care through professional coordination and integral
clinical focus. It is necessary to establish mechanisms and synergies to improve relations
between the different care levels, offering a choice of centre and specialist with
compensation per activity and quality of the results. We also ask for the analysis of the
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integration and application process of technology and health innovations, defining the
measures that are most cost/benefit effective, preserving them and strengthening them.
An improvement to the cohesion and integral coordination of the pharmaceutical policy of
the SNS with the collegiate participation of ACs in both the recording and decision making
regarding financing, while also establishing rigorous and effective mechanisms pre- and postuse of pharmaceutical supplies.
EPILOGUE
Today, many doctors have lost their faith in our political powers: the altruism that is
requested of the profession is in contrast with the current behaviour of economic agents;
some are even asking why we must accept ethical standards that others do not practise,
especially when the public powers abuse this situation, overloading health professionals of
the SNS.
We could simply monitor our own interests; limit effort, look the other way or articulate
collective pressure to minimise the impact on salaries and professional workforces. However,
being a doctor means going above and beyond: professionalism incorporates a collective
dimension (we must all safeguard this) and a social projection (we must rescue the weakest,
who are the patients).
“Nothing new under the sun”. Three other comments made by Rudolf Virchow in the 19th
century will help us to understand why medicine has been and continues to be much more
than a profession and why doctors have always been much more than public employees: “I
fear poverty more than Koch’s bacillus”; “The physicians are the natural attorneys of the
poor,” and “Medicine is a social science, and politics is nothing more than medicine on a grand
scale.”
Madrid, 29 October 2011
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194
Informed Consent in Medical
Practise
195
Council for Official Medical Associations), hosted on 29 May 2010, adopted the agreement
Derecho Médico y Visado (Central Commission for Deontology, Medical Law and
Endorsement), on:
INFORMED CONSENT IN MEDICAL PRACTISE
Introduction
Consenting to medical care has been linked to the modernisation of the doctorpatient relationship with the loss of the supremacy of the principle of beneficence in favour
of the principle of patient autonomy.
The Hippocratic Oath was inspired by the principle of beneficence, which is
understood as the duty of the doctor to metaphorically put himself in the patient’s position
when acting and choosing the care he deems most favourable and which he would choose
for himself; this implies avoiding anything that harms or damages the patient, seeking the
maximum benefit possible for the patient.
Thomist and Kantian theories drove the modern thought in which the capacity of
the human being to understand and choose is recognised, therefore, he can direct his
conduct through personal autonomy. All of this gives rise to the principle of autonomy,
which considers that it is the person himself who is in the best condition to understand,
decide and choose what is most favourable to himself.
The social group is expressed through the principle of justice, establishing the
criteria for the just distribution of resources and achieving maximum benefit for the
greatest number of people, but without forgetting the specific needs of minorities or
individuals.
All of this has significantly influenced the doctor-patient relationship. Firstly, in
terminology, as currently the term doctor-patient is imposed, dismissing the infirmus as a
person from whom illness deprives the ability of making decisions regarding his self, which
justified the fact “the doctor decides what is best for the patient, without considering the
opinion of the patient.”
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The Belmont Report, published in 1973, which is a directive for bioethics and
deontology, included informed consent as a procedure for fulfilling the principles of
beneficence, autonomy and justice in medical care.
In Spain, the first legal reference to the consent of the patient as a right appears in
the General Health Law of 25 April 1986, which details patient rights in article 10 and the
right of the patient to decide between diverse options, with his consent to any intervention
being necessary, detailed in article 6. The same article considers the need for prior
information in order to be able to exercise the right to decide and choose.
All of this introduced a series of problematic situations in clinical practise which
have slowly received responses. However, the new rights of patients and users continue to
be a challenge for good medical practise when the duty of personalising each medical act in
scientific, technical, legal and deontological terms is imposed on the doctor.
The development of article 10 of the General Health Law has been partially done in
some autonomous communities, and completely done at a state level with Law 41/2002 on
Patient Autonomy and Rights and Obligations regarding Clinical Documentation and
Information. Important core principles of this law are: 1) The right to privacy; 2) The right
to receive care information, including clinical and epidemiological information; 3) The right
to consent to any medical action, with particular reference to informed consent; 4) The
clinical history is considered as the objective expression of the fulfilment of the duty of
doctors regarding these patient/user rights; and 5) The right to freely and voluntarily
decide and to refuse to receive information and treatment.
Meanwhile, on 1 January 2000, the European Bioethics Convention came into
effect, the predecessor of which was the Oviedo Convention, a document that was
especially concerned with protecting minors and people with mental disorders, in terms of
care, understanding that their lack of maturity or the affectation of their mental abilities
impeded or hindered their understanding and ability to choose (basic pillars in the
autonomy recognised in the doctor-patient relationship).
Informed consent
Communication between the doctor and the patient is a constant flow of
information between both parties and its continuity expresses the acceptance and consent
of both parties. In this relationship, which is continued in time, when the patient is
hospitalised and at periodic external consultations, the doctor considers the patient’s state
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of health and makes suggestions. The patient declares his wishes with regards to the
actions the doctor must put into practise.
New legislation has come to demand that these actions are objectively reflected in
writing and that the fulfilment of the doctor’s duties to inform and obtain the patient’s
consent is recorded.
As such, the expression “informed consent” has been coined, meaning granting
consent to the action of a health professional, once the relevant, sufficient and necessary
information about the action has been received, enabling the patient to decide whether he
deems it favourable to him.
Informed consent has two parts: Information and Consent, regarding which Law
41/2002 states:
1. Information: Article 4. Patients have the right to know, for the purpose of any
action in the scope of health, all the information available regarding said action (…).
The information, as a general rule, will be provided verbally, with a record of this
being made in the clinical history. It must comprise, as a minimum, the purpose and
nature of each intervention, its risks and its consequences (…). It will be truthful, it
will be communicated to the patient in a manner that is understandable and
appropriate to his needs and it will help the patient to make decisions in
accordance with his own free will (…). The owner of the rights to the information is
the patient. The people linked to the patient, whether family members or commonlaw relations, will also be informed to the extent the patient expressly permits or
implies.
Article 9. The patient’s refusal to receive information is limited by the interests of
the health of the patient himself, third parties, the community, and the therapeutic
requirements of the case. When the patient expressly declares his desire to remain
uninformed, his wishes will be respected and a record of this will be noted, without
prejudice to the obtainment of consent prior to the intervention.
It also states that the physician will provide the patient, before seeking his
written consent, the following basic information:
a) The relevant or significant consequences that the intervention will
have.
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b) The risks in relation to the personal or professional circumstances of
the patient.
c) The probable risks in normal conditions, in compliance with the
experience and status of science, or those directly related to the kind
of intervention.
d) The contraindications.
The doctor responsible must consider, in each case, that the more doubtful
the result of an intervention, the more prior written consent of the patient is
necessary.
2. Consent. Article 8 states: Every action in the scope of the health of a patient
requires the free and voluntary consent from the person involved (…). Consent will
be, as a general rule, verbal. However, it will be given in writing in the following
cases: surgical intervention, invasive diagnostic and therapeutic procedures and, in
general, the application of procedures that imply risks or issues of a known and
foreseeable negative repercussion on the health of the patient.
There are exceptions to the need to obtain consent (expressly established in
article 9.2 of Law 41/2002):
a. When there is a risk to public health, due to health reasons
established by law. In any case, once the pertinent measures have
been adopted, in compliance with the guidelines established in
Organic Law 3/1986, the legal authority will be notified within a
maximum of 24 hours provided that the measures include the
obligatory admission of people.
b. When a serious, immediate risk to the physical or psychological
integrity of the patient exists and it is not possible to obtain his
authorisation, therefore, when the circumstances permit it, his family
members or common-law relations should be consulted.
From this, it can be deduced that informed consent is necessary in:
1) The usual clinical relationship in which information is conveyed in a verbal and
continued manner, and the patient tacitly or expressly accepts it. A record of these
actions must be made in the clinical history. When dealing with terminally ill
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patients or patients in a state of progressive deterioration, their wishes and
declarations, noted in the clinical history, may be applied after, when the patient
can no longer express himself, similar to advance directives or prior instructions, if
the former document has not been drawn up.
2) Situations involving the undertaking of specific medical acts (surgical intervention,
invasive diagnostic and therapeutic procedures, procedures that entail known or
anticipated risks or issues with a negative effect on the patient’s health). In these
cases, applying what is set out by the law, it is necessary to complete a written
document that contains: the nature of the medical action, its technical description,
the hoped benefits of the action, the risks and complications that may arise, the
possibility of counteracting said risks; it will also detail the possible alternatives and
the risks and benefits of each of them; and the document will also note the
consequences the refusal to receive treatment may have. The document must be
personalised when noting the specific risks to the patient, whether due to his
personal or professional characteristics, etc. Before signing the final document, it
must be stated that the patient has been able to ask the doctor all the questions he
deems necessary and that all of his doubts have been resolved.
Once the first part, corresponding to the information, has been completed, the
second part of the document must be completed. This part contains the patient
consent form, which is essential as it indicates the patient’s acceptance of being
subjected to the specific medical act, having considered all the information
received.
3) The patient must understand and authorise the use of his data for teaching and
research purposes. In clinical trials, informed consent is regulated and protocolled
specifically in Royal Decree 223/2004 on Clinical Trials.
In view of this, valid consent requires:
1. Capacity of the patient to understand the explanations the doctor gives
regarding his action.
2. Capacity of the patient to choose with maturity and liberty what he
considers most favourable to himself.
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The person’s capacity for understanding, judgement and reasoning, along
with his capacity to freely choose, constitute the pillars of autonomy, which is
characteristic of the person who expresses himself in all areas of life and, therefore,
in the doctor-patient relationship.
This means, in principle, that it is the patient who must receive the
information, choose and make a decision involving himself.
However, in practise we may face the following situations:
1. The patient of legal age and capacity. In our culture, and in the culture of the
majority of resident immigrants in Spain, it is normal for the patient to attend the
doctor or hospital in the company of his family members, whether they are legally
linked or live together. However, according to law, the person who will receive the
information and who must give consent is the patient: his companions, who often
participate in the doctor-patient relationship, share the information and help the
patient to make decisions.
As such, we recommend, when a patient is hospitalised and he is in a condition to
decide, suggesting that he designates someone/several people who will support
him in this care relationship. A record of the identity of this person/these people
will be made in the clinical history and subsequent conflict will be avoided,
especially if the patient, in his clinical development, loses the capacity to decide.
Although the family members receive information, provide their opinions and help
the patient to make decisions, it will be the patient who signs the informed consent
form.
2. People who suffer from mental disorders, at least occasionally, need family
members, carers, administration representatives, etc. to accompany or support
them in the care relationship. These are the people who help the patient to make
decisions, or they make decisions for them, acting “as their representative.” This is
supported in Law 41/2002, which says “When the patient, according to the criteria
of the doctor who is attending to him, lacks the capacity to understand information
due to his physical or psychological state, this information will be communicated to
the people linked to him through family or legal relations.”
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In these cases, the doctor must be especially careful as the autonomy of the patient
disappears and the person who his representing him acts, like the doctor, through
the principle of beneficence, meaning the doctor assumes responsibility for the
duty of guarantor, which may be more beneficial and favourable to this patient as
he has increased aspects of judgement (medical knowledge, professional
experience, etc.). In the event the doctor deems the decision made by the guardian,
legal representative or carer of the patient to not be the most favourable for him,
he may turn to the attorney general who, as protector of minors and people who
are incapable, will intervene, subjecting the case to the appropriate criteria.
The aforementioned European Bioethics Convention states that the individual who
suffers from a mental disorder should receive information and participate in the
process as far as possible. Law 41/2002 follows similar criteria when it says, “The
patient will be informed, even in the case of incapacity, in a manner that is suitable
to his possibilities of understanding, while the duty to inform his legal
representative will be fulfilled as well.”
Therefore, the doctor has the duty to take this person into account and try to
explain things in a way he will understand, gaining his trust and seeking his
acceptance of the measures that are decided as most beneficial to him. However, it
will be the legal representative or person responsible for the patient who will sign
the document.
Hospitalisations against the wishes of the person (compulsory admissions) due to
mental disorders are considered in article 763 of the Civil Indictment Law; they may
be undertaken via legal communication and protection that verifies and authorises
hospitalisation as a measure that is favourable to the person, keeping the individual
hospitalised only for the minimum time required for an improvement or curing of
the patient.
3. Minors. The age of 18 brings with it the legal recognition of civil capacity as the right
“to govern the person and manage property,” meaning, it recognises autonomy in
decision making regarding oneself and one’s belongings. Up until this age, the
person’s parents have the right to exercise parental rights and duties (act/decide
representing their children), always “for the benefit of the minor.”
The acquisition of mental capacities and strength of will in a manner that is gradual
and parallel to the biological evolution of the minor leads us to progressively
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recognise his ability to make decisions, particularly regarding matters that affect
“his personality,” or, in other words, his emotions, feelings, etc.
In this regard, the Civil Code recognises that, in parent separation processes, the
minor will be heard by the judge, and it states, “and always when he is over twelve
years old,” in other words, a child who is older than 12 years old is deemed to
already be capable of expressing correct opinions regarding what is most favourable
to him in personal and family matters.
The Criminal Code considers sexual conduct with a person younger than 13 years
old to always be non-consenting sexual abuse. This implies that the consent of a
minor under 13 years old is not valid and maintaining sexual relations with the
minor will always be regarded as a crime; this is important in relation to minors
under 13 years old who request the morning-after pill, given that these relations
should be reported. In minors between the ages of 13 and 16 years old, conflict
arises between respect for their privacy, maintaining the confidentiality of care, and
communicating to their parents the care service given. The best option to take is to
inform the minor of the risks of the pill and its repeated consumption, direct the
minor to sex education programmes, and make a record of the voluntary request
and the information received, with the minor assuming responsibility with his own
signature.
In civil order, at 14 years old the minor is permitted to make a will, which indicates a
recognition of the minor’s capacity to comprehend and evaluate actions and the
consequences.
At 16 years old, emancipation is permitted with the consequent abandonment of
the family home and even the limited administration of material assets.
The European Bioethics Convention says that “the opinion of the minor will be
taken into consideration as a factor that will be more determining depending on his
age and degree of maturity.”
In this regard, Law 41/2002, article 9.3, establishes the following: “…when the
minor patient is not intellectually or emotionally capable of understanding the
scope of the intervention. In this case, consent will be given by the legal
representative of the minor, after the minor’s opinion has been considered, if he is
over twelve years old. When dealing with incapable but emancipated minors, or
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minors who are sixteen years old or over, consent by representation is not valid.
However, in the event of an action with a serious risk, according to the criteria of
the physician, the minor’s parents will be informed and their opinion will be
considered in the corresponding decision making process.”
On the other hand, article 13.4 in Organic Law 2/2010, of 3 March, on Sexual and
Reproductive Health and the Voluntary Termination of Pregnancy, establishes the
following:
In cases involving women of between sixteen and seventeen years old,
consenting to the voluntary termination of pregnancy corresponds
exclusively to them, in accordance with the general regulations applicable to
women of legal age.
At least one legal representative, the father or mother, people with parental
duties and rights, or the guardian of the woman between these ages must be
informed of the woman’s decision.
This providing of information may be disregarded when the minor claims
that it will essentially provoke a serious conflict, via certain danger of
domestic violence, threats, coercion, and abuse or if a situation of alienation
or neglect may occur.
Being 16 years old or more, means the minor is classed as a mature minor 8, which is
very important as we have seen in healthcare, given that the minor’s consent is
valid for all general medical acts with the sole exception that has already been
mentioned.
The relationship of the doctor with the minor and the respecting of his rights, poses
a certain legal requirement of the doctor as well as an even greater deontological
requirement: that of personalising each case and adapting to the intellectual,
cultural, personal and familial level of each minor patient to customise the
information and obtain his acceptance or consent during the process.
8
See the Organización Médica Colegial de España’s Declaration on MEDICAL ETHICS IN
CARING FOR THE MATURE MINOR. January 2008
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When parents make decisions for the minor, the doctor must assess whether these
decisions favour the minor. If they do not, the doctor must turn to the attorney
general who, as protector of minors and people who are incapable, will intervene
and try to avoid the harm of the minor.
Practical recommendations of informed consent
1.
Legislation and deontology oblige the doctor, regarding informed consent, to
fulfil his duties of informing and obtaining consent.
2.
The aforementioned implies the capacity of the doctor to put himself in the
position of the patient and inform him while addressing his cultural level,
adapting and personalising the information such that what is relevant,
sufficient and necessary for the patient to make a decision in accordance with
the real status of the illness and himself is communicated.
3.
Bearing in mind the organisation of care and the time the doctor has,
informed consent must be used with common sense and good practise in
order to achieve the objective, in the minimum time possible, of the patient
understanding the important information in order to know what the medical
act to which he is subjecting himself consists of, the risks he is acknowledging
and the anticipated results.
4.
An informed consent form that is insufficiently completed – which states the
general risks and complications, without detailing the specific risks in
accordance with the personal and occupational characteristics of the patient –
is not legally or ethically acceptable.
5.
The act of informing and obtaining informed consent is not a bureaucratic act
and it requires a prior personal relationship in which an understanding of the
patient, his needs and circumstances has been reached. Giving the patient a
standard informed consent document for him to read and sign, before the
intervention, without receiving the prior verbal and personalised clinical
information, is contrary to medical deontology.
6.
In the case of minors, the doctor must consider what the law states regarding
the progressive capacity of the minor to participate and decide in his care
process, which means he must be informed and his opinion taken into
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account. When the minor is over 16 years of age, his consent must be
obtained. However, when deemed necessary and appropriate, his parents will
be informed and their consent must be granted when the minor is under 16
years old.
7.
In the case of people with mental disorders, the doctor will inform the patient
and will consider his opinions, as far as the patient is capable of understanding
and communicating with the doctor. In these cases, the doctor must request
information regarding the legal situation of the patient, his incapacity and the
consequent appointment of a guardian, with the guardian being the valid
representative and the person who will sign the informed consent document.
The professional will consider that when it is the guardian, legal
representative or person responsible for the patient who makes a decision,
although this person’s obligation is the benefit of the patient, he acts from his
own point of view and interests, meaning the doctor becomes the guarantor
for the patient, supporting actions that may be more favourable for him.
8.
If the patient lacks a legal representative, consent will be given by the people
linked to him by family or legal relationships.
9.
In the case of minors as well as patients with mental disorders, when the
doctor considers the rights of the patient to be in danger he will turn to the
attorney general who is responsible for representing and protecting minors
and people who are incapacitated.
10.
The doctor must be aware that each patient may involve a different conflict,
meaning he will often have to address the duty of recognising the legal
requirement and applying it. He will also have to, through ethical reflection,
put into practise the measures that are personalised and adapted to each
situation, always focussing on the exercising of authentic patient autonomy,
when he may exercise it, or the duty of beneficence, guaranteeing what most
and better favours the interests of the patient.
Madrid, 31 May 2010
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Declaration on Healthcare for
Undocumented Immigrants
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DECLARATION ON HEALTHCARE FOR UNDOCUMENTED
IMMIGRANTS
(Reference: Decree--‐Law 16/20112 and Royal Decree 1192/2012 which regulates the condition of the
Sistema Nacional de Salud insured individual)
The Organización Médica Colegial de España (Spanish Collegiate Medical
Association, hereinafter OMC) as a corporation of public law that aims to regulate the
practise of the medical profession, with special attention being paid to its deontological
framework, is concerned to see the enactment of legal guidelines and regulations that, as
they are understood and applied, could generate problems of health neglect and serious
conflicts at care points.
Health professionals are proposing different measures to address this situation,
including conscientious objection before the legal regulations and even civil disobedience
or revolt, responses that cannot be confused in any way.
In light of the numerous hypotheses and interpretations that the development of
the legal regulations have raised in the different social, political and health spheres, and for
the purpose of offering guidelines adjusted to the deontological framework of the medical
profession, the following is offered:
DEONTOLOGICAL ANALYSIS OF THE WITHDRAWAL OF HEALTHCARE TO IMMIGRANTS
WITHOUT A RESIDENCY PERMIT
The situation that has been generated due to the withdrawal of the right to
healthcare in the Sistema Nacional de Salud (National Health System, hereinafter SNS) of
people without a residency permit raises issues in two areas that are different in scope and
nature:
a) Professional ethics, appropriate to the OMC, which directly and immediately affects
doctors who, as they are responsible for the care given to a group of citizens, are
notified that these patients will imminently cease to have the right to healthcare in
the terms in which they were receiving it.
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b) Social policies, appropriate to the organisations of democratic representation, which
may also express their opinion and proposed organisations, associations and
institutions, whether they are public or private.
From the perspective appropriate to the OMC, the following considerations are
formulated:
1. EMERGENCY CARE
In emergency situations or states of need, “every doctor, whatever his speciality or
area of practise, must provide a sick or injured person with emergency care” (article 6.1. of
the Code of Ethics and Medical Deontology [CEMD]).
2. CONTINUITY OF CARE
In article 11 of the CEMD, it is established that the doctor must preserve “the
continuity of care” for the patient whose care is suspended due to a loss of trust, and he
must communicate this with him “sufficiently in advance,” such that another doctor may
take over the care process and can be sent the information required to guarantee the
continuity of treatment.
For example, if an interruption to the care of a patient due to reasons different to
the wishes of the patient (for example, due to a legal change) were to occur, the doctor
may not interrupt the patient’s care without further ado: he must help, in the appropriate
manner, the continuity of care when necessary.
3. CONSCIENTIOUS OBJECTION
In the event that, due to the application of a law, an SNS doctor were not able to
provide care to patients with undocumented status in Spain, it must be considered if
conscientious objection is viable.
“Conscientious objection is understood as the refusal of a doctor to subject himself,
due to ethical, moral or religious beliefs, to conduct that is demanded of him by law, by
mandate of authority or by administrative decision, which would seriously violate his
conscience” (article 32.1 of the CEMD).
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In article 33.3 of the same Code, it is established that the doctor must inform the
personal responsible for guaranteeing the services (in this case, his immediate superior)
and subsequently the medical association of his stance as conscientious objector to a
certain situation for the purpose of receiving the advice and help necessary. This is relevant
as “No kind of prejudices or advantages for the doctor who invokes conscientious objection
may be derived" (article 35 of the CEMD).
On the contrary, conscientious objection would not be valid if the measures
adopted by the health authorities in their respective area were to guarantee, with the
designated organisational measures, healthcare that is appropriate for these special
circumstances.
4. CIVIL DISOBEDIENCE
Another differing aspect, which is outside the law, would be “civil disobedience” or
“revolt,” which consists of an active and direct opposition to a law that is deemed unfair
and which is challenged with the intention of being abolished, accepting the consequences
of repression and even provoking it. Said measures are different to the objectives the OMC
must satisfy as a corporation of public law in the exercising of its own public jurisdiction.
FINAL CONSIDERATION
The OMC is very aware that the health authority must address an extraordinarily
complex situation of economic adjustments that call for extreme measures for the purpose
of making the public health system viable for the benefit of all citizens, who sustain it with
their taxes. The adoption of reforms that drive economic sufficiency and care management
efficiency seems inescapable in order to avoid cuts to basic services that serve the whole
population.
On the other hand, we believe how administrative procedures are regulated is not a
medical issue: this is something the central government must determine in collaboration
with autonomous communities. The doctor, at all times, must attend everyone, regardless
of their legal status.
Having reached this point, one must recognise that management and
communication failures have occurred. The first of these has contributed to so-called
“health tourism” which involves a cost of considerable magnitude for the public health
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system. The second, which is more recent following the publication of the legal guideline,
has resulted in disorientation and concern among health professionals.
However, we believe it would be wrong to withdraw healthcare from
“undocumented immigrants,” who, at the same time, are the result of an erratic
immigration policy. From a health policy perspective, we find ourselves before a serious
situation that requires clear answers and we also believe it is necessary to evaluate the
economic, social and health impact of the measures that are to be adopted.
In this regard, autonomous communities must determine the best way for services
and professionals to be able to offer healthcare in these cases.
It is expected that, if the health authorities do not urgently adopt the appropriate
measures, this could generate care distortion that would undoubtedly have an effect on
the rest of the population, especially on the emergency services. Failure to do so, which is
the intended objective of the legal standard and far from being achieved, would instigate
undesirable side effects, with the perverse impact of increased spending.
From a humanitarian perspective and one of good governance, we believe the
Spanish Government must offer solutions that prevent a dilemma for Spanish health
professionals between the legislation and deontological propositions, but without ignoring
the economic effects that require a solution in the corresponding administrative channel.
In this scenario, the announced measures of billing countries of origin are acceptable, but
healthcare must not be withdrawn from those people who need it, especially chronic
patients.
We believe that, as a consequence of this objective, the health authority will have
the faithful collaboration of medical professionals who, due to ethical and deontological
reasons, must now declare their concern for the possible effects of the legislation that will
imminently be applied (it should be noted that in compliance with the Law on the Health
Professions – article 4.7 – the practise of medicine will be undertaken according to the
values and principles contained in legal and deontological codes).
As the Organización Médica Colegial de España, we demand respect for our actions,
which are based on the fulfilment of the deontological duties of emergency care, a state of
need or requirements for the continuity of care.
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212
The Ethics of
“Pharmacotherapeutic
Guides” and the “Protocols for
Therapeutic Interchange”
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Council for Official Medical Associations), hosted on 16 November 2012, adopted the
agreement to unanimously approve the following declaration drawn up by the Comisión
Medical Law and Endorsement) on:
THE ETHICS OF “PHARMACOTHERAPEUTIC GUIDES” AND THE
“PROTOCOLS FOR THERAPEUTIC INTERCHANGE”
Introduction
For a few years, our Sistema Nacional de Salud (National Health System, hereinafter SNS)
has been using “Pharmacotherapeutic Guides” (PTG) and more recently, especially in
hospitals, “Protocols for Therapeutic Interchange” (PTI).
PTG state the guidelines, procedures and recommendations for the use of drugs in the
scope of their application. They contain the description of the medication, approved for
this means (hospital, area of health, primary care, etc.), classified in therapeutic groups
and basic information about each of them in order to facilitate their management.
PTI is a procedure through which a medicine is substituted by another of different or
similar composition, but of which a similar therapeutic effect and a similar profile of
possible adverse effects to the medicine substituted are expected when administered to a
patient in an equivalent dosage.
Both procedures are ordinarily prepared by “Phamarcy Commissions” or by “Technical
Commissions for the Evaluation and Selection of Medication” that include wide
professional representation in their participants. The task of these commissions is to
analyse the scientific information available and draw up agreed documents designed to
help with prescription.
Both documents are prepared as help tools when deciding on the drug to be used for a
specific patient in a situation of constant and rapid pharmacological innovation in which
the advantages and distinguishing characteristics of medication are not always clear or
are sufficiently contrasted in scientific literature. They are also tools to rationalise the use
of medication, including the saving aspects in the prescription without reducing its
efficiency.
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Uncertainty arises if the PTG and PTI share an infringement or restriction to the doctor’s
freedom of prescription. It is for this reason that the Comisión Central de Deontología
(Central Commission for Deontology) draws up this declaration.
Reference documents
In 1994 the World Health Organisation (WHO), in its “Guide to Good Prescribing: Action
Programme on Essential Drugs”, referred to the selection of drugs and indicated some
criteria for this: “the selection of drugs is a continuous, multidisciplinary and participatory
process that must be developed based on efficacy, safety, suitability and cost in order to
ensure their rational use.”
The International Pharmaceutical Federation approved in Vancouver (September 1997)
the Declaration on Principles in which it establishes the concept of therapeutic
interchange: “The act of dispensing a therapeutic alternative in accordance with a
protocol that is previously established and agreed on between he who prescribes and the
pharmacist, or following a prior individual consultation with he who prescribes.”
The Code of Ethics and Medical Deontology, of 9 July 2011, establishes in articles 7.2, 7.4,
23.1, 23.6 and 26.1 the following:
7.2. The doctor is the main agent in protecting health and he must monitor the
quality and efficiency of his practise. The doctor is also the main instrument in the
promotion, defence and restoration of health.
7.4. The doctor must be conscious of his professional duties to the community. He is
obliged to ensure maximum efficiency in his work and the optimal performance of
the measures society puts at his disposition.
23.1. The doctor should have freedom of prescription, with respect shown for
scientific evidence and authorised indications, enabling him to act with
independence and a guarantee of quality.
23.6. A prescription is the corollary of the medical act and the doctor will be
responsible for this. If there is a modification to the contents of a prescription that
may affect treatment, the ethical responsibility of the doctor would cease.
26.1. The doctor must preferentially employ procedures and prescribe drugs whose
efficacy has been scientifically proven.
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Comisión Central de Deontología declarations:
1. “The Doctor’s Freedom of Prescription” of 23 January 1999.
2. “The Ethics of Prescribing and Substituting Generic Medication” of 29 May 1999.
3. “Limits to the Professional Functions of Doctors and Pharmacists” of 28 November
1998.
4. “The Ethics of the Professional Relationship of the Doctor with the Pharmaceutical
Industry and Health Companies” of 1 October 2005.
5. Comisión Central de Deontología Report, of 25 February 2011, analysing the
regulations of different autonomous communities, particularly Galicia, that tend to
rationalise pharmaceutical spending.
Deontological criteria
Clinical freedom and the freedom of prescription consist of the capacity of the doctor to
choose, from the options available, the option that is most convenient to the patient after
having considered the validity, use, safety, efficacy and the economic effect that his
decision entails.
Freedom of prescription is limited and must be based on the capacity of the doctor to
prescribe a certain substance or its therapeutic equivalent, regardless of the active
ingredient or commercial name it may have.
Freedom of prescription must not be an absolute aspect that is free of obstacles and limits.
The WHO indicates that “a patient must receive the medicine that is most suited to his
clinical situation, with the most appropriate therapeutic guideline, for the necessary time
and in a manner that entails the lowest cost possible for the patient and the community.”
These reflections remind us that in the practise of current medicine the social and
economic considerations, in addition to the essential scientific and ethical considerations,
are inseparable and inescapable in decision making.
The traditional principles that preside over the relationships between doctors and
pharmacists continue to be applicable. In other words, the doctor prescribes and the
pharmacist dispenses, maintaining between them a relationship of cooperation aimed at
optimising the use of drugs in both a therapeutic and economic sense.
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Freedom of prescription and patient rights must be combined with the responsibility of
appropriately managing the economic resources that society provides the doctor with.
Prescribing with responsibility and moderation is a deontological duty.
The health administration, whatever its area of competency, has the duty to ensure the
sustainability of the public health system and therefore, of rationalising spending. To do
this, it must fulfil its duty to organise, control and optimise pharmaceutical spending.
Conclusions
1.
The doctor’s freedom of prescription, which is based on prescribing the
substance that he considers appropriate for each patient, may not be violated
by the substitution of the prescribed drug by another of different composition
even though it is considered a “therapeutic equivalent,” unless the person
responsible for the prescription agrees to the change.
2.
“Pharmacotherapeutic Guides” and “Protocols of Therapeutic Interchange,” in
addition to any other prescription help document, must be based on scientific
criteria and they must also be correct from an ethical point of view.
3.
The doctor may not forget that the resources set aside for prescriptions pertain
to society as a whole and they are limited. As such, the doctor is particularly
obliged to prescribe with rationality and good economic sense. The prescription
of drugs of a high price is not ethically acceptable when a drug’s efficacy is
equal to that of other drugs that are available at an inferior cost.
4.
It is difficult to justify the health administration making a drug available to
doctors and society and then subsequently hinder or penalise its prescription.
5.
The doctor must be willing, before the corresponding health or professional
authority, to justify and provide explanations for his prescriptions, the
therapeutic changes he may carry out and, in general, his prescribing
behaviour.
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218
Institutional Declaration on
the Draft Bill on Abortion
219
Institutional Declaration on the Draft Bill on Abortion
The General Assembly of the Organización Médica Colegial de España (Spanish Collegiate
Medical Association, hereinafter OMC) has today, Saturday 15 February 2014, approved
an institutional declaration on the Draft Bill for the Organic Law on the Protection of the
Life of the Conceived and the Pregnant Woman’s Rights in which it expresses a series of
proposals for the text approved by the Government.
The General Assembly of the OMC; in which the Standing Committee of the OMC, the 52
presidents of Spain’s medical associations and the nine representatives of the national
committees participate, has approved this declaration after analysing the report of the
corporation’s Comisión Central de Deontología (Central Commission for Deontology) and
Servicio Jurídico (Legal Service).
Declaration text:
INTRODUCTION
1. The Code of Ethics and Medical Deontology (CEMD), in article 51.1, states that:
The human being is an aim in itself at all stages of the biological cycle, from
conception to death. The doctor is obliged, in any of his actions, to safeguard
the dignity and integrity of people in his care.
Without disassociating oneself from this deontological principle against the voluntary
termination of pregnancy (VTP), it is necessary to recognise the existence of serious
situations that occur and require the consideration of conflicting values between the
woman and the conceived.
2. The Draft Bill for the Organic Law on the Protection of the Life of the Conceived and
the Pregnant Woman’s Rights considers VTP legal in two scenarios:
a. When a serious risk to the life or physical or psychological health of the
woman exists.
b. When the pregnancy is the result of a previously reported rape.
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3. The deadlines and the scenario of a foetal anomaly or illness that is incompatible with
life, which is included in current legislation, are eliminated. Therefore, no pregnant
woman carrying a foetus with serious disorders may terminate her pregnancy unless a
malformation or serious illness of the foetus, as certified by the corresponding
specialist, is considered to entail a “serious risk to her psychological health,” and this
must be certified by two psychiatrists who are not related to the centre that will
undertake VTP.
4. The Draft Bill for the Law on Conscientious Objection of the Doctor recognises “the
right of health professionals (…) to abstain, due to reasons of conscience, from
participating or collaborating on VTP.” “Collaborating” may be interpreted as being
able to debate any type of information against the request of the pregnant mother
expressing her desire to abort the pregnancy, which will cause bother, delays and
difficulties, especially in situations and places with just one option, that of the family
doctor.
Article 55.3 of the CEMD declares that:
The doctor must provide the pregnant woman with the appropriate,
reliable and complete information regarding the progress of the
pregnancy and foetal development. Refusing to give, hiding or
manipulating information in order to influence the decision of the
mother regarding the continuation of her pregnancy does not
comply with medical ethics.
5. The recent introduction of the transposition of Directive 2011/24/EU from the
European Parliament and Commission, related to the application of patient rights in
cross-border healthcare, will enable any Spanish citizens who wish to terminate
pregnancy within the time periods established in the respective EU countries, except
Ireland and Malta, may do so wherever they wish, assuming responsibility for the
costs this entails, in the event it this service is not financed by the Spanish Sistema
Nacional de Salud (SNS, the National Health System).
CONCLUSIONS AND PROPOSALS
1. The public powers are responsible for balancing different emotions within the
constitutional principles and under the guardianship of human rights, providing
solutions through laws that are agreed as much as possible, especially in fundamental
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aspects that directly influence the chapter of rights and freedoms.
2. The woman who, due to varying circumstances, decides to voluntarily terminate her
pregnancy must not be considered or defined beforehand as a mentally ill patient.
The responsibility of certifying a “serious risk to her psychological health,” except in
the scenario in which a prior, serious psychological pathology exists, performed by
two doctors as a condition to being able to terminate the pregnancy within the
established time frames remains in the hands of the criteria of each professional. Such
an important decision may not be left in the hands of third parties.
3. However, the Consejo General de Colegios Oficiales de Médicos (General Council for
Official Medical Associations, or CGCOM) is aware of the inequality that may be
derived from VTP due to the transposition of the European Directive on Cross-Border
Healthcare.
4. VTP must be decriminalised in the event of a serious malformation or illness that is
incompatible with life in the foetus, balanced with what is established in the
Convention on the Rights of Persons with Disabilities, which was ratified by Spain in
2008.
5. It should be added to the law regarding the minor who is 16 or 17 years old and who
requests a VTP that at least one of the minor’s legal representatives (the father or
mother, someone with parental rights and duties, or a legal guardian) must be
informed of the woman’s decision. This information will be avoided when the minor
alleges (and this is certified by the social services) that it will instigate a serious
conflict, which manifests itself as a certain danger of inter-family violence, threats,
coercion, abuse or a situation of alienation or neglect.
6. It is necessary to actively promote and favour specific policies and policies of
economic support for responsible maternity and especially families with disabled
children and specific care needs.
7. It is necessary to contemplate set sexual and reproductive education, especially
among young people, with particular attention being paid to unprotected sexual
relations, the prevention of unwanted pregnancy, the knowledge of contraceptive
methods, and awareness of free access to the morning-after pill in health centres and
family planning centres.
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8. In the section detailing who may perform the VTP, it states that “VTP must be carried
out by a doctor or under his guidance.” This should add “by health personnel who are
qualified for the task.”
9. Conscientious objection of the doctor to VTP is permitted in direct actions but it must
not include indirect actions. Therefore, the expression “collaborating” should be
eliminated, leaving “abstain, due to reasons of conscience, from participating in the
voluntary interruption of pregnancy.”
Madrid, 15 February 2014
223
224
Report on the Possible
Contradictions that Royal
Decree 16/2012, of 20 April,
on Urgent Measures to
Guarantee the Sustainability
of the Health System, May
Have with Ethics and
Deontology
225
REPORT ON THE POSSIBLE CONTRADICTIONS THAT ROYAL DECREE
16/2012, OF 20 APRIL, ON URGENT MEASURES TO GUARANTEE
THE SUSTAINABILITY OF THE HEALTH SYSTEM, MAY HAVE WITH
ETHICS AND DEONTOLOGY
Royal Decree 16/2012, which has recently emerged, obliges doctors to perform a
profound reflection from an ethical and deontological perspective. However, we believe
that performing an overall analysis to assess whether a legal guideline that is as extensive
and complex as this one is complies with medical ethics and deontology is difficult, given
that this analysis is usually applied to specific behaviours that are carried out by certain
individuals and in particular circumstances. However, we note the following
considerations on the following aspects:
a) The impact on citizens who require healthcare. We must consider that some
proposals that have been gradually introduced and which have finally appeared
in the Royal Decree impact on the quality of healthcare and therefore they
could lead to a situation that is contrary to the guidelines of medical ethics and
deontology, in the articles we highlight as reference points in this document.
b) The sustainability of the system. We are of the unanimous opinion that the
current Sistema Nacional de Salud (National Health System, or SNS), with the
extension and quality of its services, is not sufficiently financed. Our leaders are
responsible for enacting the measures that guarantee the sustainability of the
SNS.
c) The streamlining of the SNS happens due to its efficacy and efficiency and
through the adaptation of its services to the current situation. Measures must
be carefully adopted following reflection, therefore safeguarding the principle
of equality.
Negative aspects of the regulation⠀⠀
1. Some of the measures adopted will probably not result in a saving, instead, when
they are applied, they will generate more costs, which would be contradictory to
the objective of maintaining the sustainability of the SNS.
2. In general, there are numerous measures from which situations that result in an
ethical and deontological conflict for doctors may arise as doctors cannot attend a
patient who has come to receive care for chronic illnesses and the fact that this
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regulation ceases to recognise this right. This situation may be identified as patient
neglect in some occasions, which would be contrary to medical deontology.⠀
Through this overall analysis, we consider:
1. The adaptation of services appears necessary and obligatory due to the
current economic situation in order to maintain the sustainability of the SNS.
Royal Decree 16/2012 has not addressed this with the necessary reflection and
consideration.
2. The necessary adjustments could have been performed with more equality,
emphasising the range of services such that basic services, which are
determined as such, are within the reach of all citizens, while other
complementary or more extraordinary or exceptional services are only
available to those who meet certain requirements. This focus would be more
respectful of equality.
3. Royal Decree 16/2012 deserves a specific, professional response which
identifies (in general and as far as possible) the situations that entail a risk of
deontological conflicts, amongst other aspects. Likewise, situations in which
failure to attend to a patient (risks of infection or aggressive conduct, etc.)
results in a risk to the patient himself and third parties with the right to the
protection of their health and integrity also deserve a response.
4. It must also identify the situations that, when applied, generate more costs
than savings.
5. This analysis must be performed at the heart of the Consejo General de
Colegios Oficiales Médicos (General Council for Official Medical Associations,
or CGCOM) and by a group in which the Comisión Central de Deontología
(Central Commission for Deontology, or CCD) is represented in addition to the
professionals whose speciality of practise is most affected, such is the case
with family doctors, those who work in infectious illnesses, chronic illnesses,
etc.
The articles of the Code of Ethics and Medical Deontology that may be viewed as
compromised in some situations that are derived from the literal application of this Royal
Decree would be:
Ch. II. Art. 5.2:
The doctor should attend all patients with the same diligence and
application, free of any kind of discrimination.
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Ch. II. Art. 6.1:
Every doctor, whatever his speciality or area of practise, must
provide a sick or injured person with emergency care.
Ch. II. Art. 6.2:
The doctor will not abandon any patient who needs his care, not
even in situations of disaster or epidemic, unless he is obliged to do
so by the corresponding authority or if an imminent or inevitable vital
risk to his person exists.
Ch. II. Art. 7.2:
The doctor is the main agent in protecting health and he must
monitor the quality and efficiency of his practise. The doctor is also
the main instrument in the promotion, defence and restoration of
health.
Ch. II. Art. 7.4:
The doctor must be conscious of his professional duties to the
community. He is obliged to ensure maximum efficiency in his work
and the optimal performance of the measures society puts at his
disposition.
Ch. II. Art. 7.5:
As the health system is the main instrument in society for healthcare
and the promotion of health, doctors must be aware to ensure it
provides the necessary requirements in quality and care efficiency,
and that ethical principles are maintained. They are obliged to report
deficiencies that could affect the correct care of patients.
Ch. III. Art. 11:
The doctor will only be able to suspend care to his patients if he were
to reach the conclusion that he does not have their necessary trust.
He will communicate this to the patient or the patient’s legal
representatives
Ch. IV. Art. 23:
The doctor should have freedom of prescription, with respect shown
for scientific evidence and authorised indications, enabling him to act
with independence and a guarantee of quality.
Ch. X. Art. 45.1:
The doctor who provides his service to the Sistema Nacional de Salud
(National Health System) must monitor and contribute to ensure he
meets the quality, sufficiency and fulfilment criteria of the ethical
principles. He will support regulations that contribute to improved
care for the sick.
Ch. X. Art. 47.1:
Doctors who occupy managerial roles in health institutions must
oversee things to ensure performances adapt to the real care needs
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of the population and the real possibilities of financing, avoiding
health services being offered without the due amount of human and
material resources.
Madrid, 2 June 2012
229
230
Central de Deontología of the
de España on the Medical
Care of the Minor in Situations
Involving the Rejection of
Treatment
231
DECLARATION OF THE COMISIÓN CENTRAL DE
DEONTOLOGÍA OF THE ORGANIZACIÓN MÉDICA
COLEGIAL DE ESPAÑA ON THE MEDICAL CARE OF THE
MINOR IN SITUATIONS INVOLVING THE REJECTION OF
TREATMENT.
The Plenary Session of the Comisión Central de Deontología, Derecho Médico y Visado
(Central Commission for Deontology, Medical Law and Endorsement, hereinafter CCD),
hosted on 30 and 31 January 2015, has drawn up this:
DECLARATION
I. Introduction
In general, the consent of the patient is the source of conflict in numerous
circumstances. This is accentuated if the patient is a minor, due to the limitations of his
capacity to consent.
Consent as a right is regulated by numerous legal and deontological guidelines that are
very precise and demanding, but which do not duly clarify conflicts that arise in practise
and the resolution of these conflicts.
Current legal and deontological guidelines recognise a progressive maturity of minors
that favours their self-determination and capacity of autonomy regarding healthcare.
However, civil law, in terms of protecting minors, establishes parents’ duties of custody
until the minor is of legal age, with the parents being obliged to represent the minor and
decide for him, always in his benefit.
In view of possible conflicts, the CCD deems it necessary to analyse and evaluate the
issues to guide decision making.
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This declaration aims to provide paediatrics specialists and doctors in general with the
necessary legal, ethical and deontological information that will facilitate their decision
making process when faced with conflicts of consent in care.
Practise demonstrates that numerous professional responsibility claims are directly
related to legal aspects, such as information, consent or confidentiality; claims related
to the scientific preparation of doctors are much less frequent.
The CCD already drew up the Declaration on the Mature Minor in 2007 in reference to
the progressive right of minors to make decisions regarding themselves.
It was in the United States of America, at the beginning of the 70s, where the legal
doctrine of the “mature minor” was progressively configured.
This doctrine is based on the so-called “rule of the mature minor,” for which parental
rights and duties, understood as direct power over a person, continue to be effective
until the minor reaches legal age however, as the minor matures, the level of parental
control must be limited appropriately. This corresponds to a degree of intelligence and
sufficient desire to validly undertake a specific legal act or exercise a right.
When applied to medical care, this signifies the capacity of a minor individual to
understand the situation he is facing and the possible treatment alternatives, along with
the anticipated consequences of each of these. This also includes knowing how to
express and defend his decisions, supported by his scale of values. When this has been
verified, the minor may decide for himself, with parental intervention moving to a
secondary level, although it is true that in serious situations or situations of significant
risk, the opinions of the minor’s parents can and should be considered and even
followed.
In medical law, the concept of the “mature minor” has been widely accepted and
strengthened by its legal recognition. Organic Law 1/1996 on Legal Protection of the
Minor indicates that “the best way to socially and legally guarantee the protection of
childhood is to promote his autonomy as subjects.” With this same idea, the European
Bioethics Convention, drawn up in Oviedo and applicable as Spanish legislation since 1
January 2000, with regards to the consent of the minor in healthcare says, “the opinion
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of the minor will be considered as a factor that will be more determining depending on
his age and degree of maturity."
It may be said that the expression “mature minor” is used to identify people under 18
years old (legal age) but with sufficient intellectual and volitional capacity to become
involved in decision making processes regarding himself. In general, it is accepted that
the rights of personality (affective aspects and health aspects in general, and sexual and
reproductive health in particular) and other civil rights can and should be exercised by
individuals from the moment they have sufficient natural judgement which, factually or
circumstantially, for many authors, occurs in the majority of people parallel to biological
maturity, and before turning 18 years old.
II. Legal regulation
Reviewing Spanish legislation, it can be determined that the first guideline that details
the participation of the minor as a patient in health is derived from Organic Law 1/1996,
of 15 January, on Legal Protection of the Minor. This law configures an image of the
minor as an active and participatory subject in social, cultural and political life. However,
the parents or legal guardian of the minor substitute him in more important decisions,
but they allow him to progressively become more involved as far as he understands
what is happening and the advantages and disadvantages to what is being offered to
him as treatment options.
Regarding the absence of a specific and precise guidelines on the consent of the minor
in healthcare in Spanish legislation, doctrine was almost unanimous in accepting the
criteria of natural capacity, which implies the possibility that recognition for the
exercising of the patient’s right to consent would depend on whether the physical and
psychological conditions (degree of maturity) are met. This would enable the acceptance
or rejection of a certain medical act, although the opinions of parents or legal guardians
must always be sought. In this regard, the important role of the doctor as a guarantor
for the rights of minors is notable, with the doctor always being guided by the aim of
achieving maximum benefit for the minor, which sometimes goes against what is
expressed by the minor’s parents.
After the European Bioethics Convention became legally applicable in Spain, its precise
references to the consent of the minor began to serve as a guide in usual medical
practise.
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Article 6.2 states: "when, according to the law, a minor does not have the capacity to
express his consent to an intervention, consent may only be given with the
authorisation of his representative, an authority or the person or institution appointed
by law. The opinion of the minor will be taken into consideration as a factor that will be
more determining depending on his age and degree of maturity."
From this, it can be derived that the guideline establishes a two-sided argument: ‘age’ as
an objective criteria and the ‘maturity’ of the minor patient in order to evaluate his
opinion as a subjective criteria. Teaching mainly considers that natural capacity is given
priority over legal capacity, given that the precept recognises, on the contrary, the
ability of the minor to authorise the practise of the intervention concerned, granting his
opinion growing importance “depending on his age and maturity.”
With regards to the second criteria (degree of maturity), it was recognised once again in
the regulatory guideline on patient rights, Law 41/2002, of 14 November, on Patient
Documentation. As determining criteria, this state law, when it refers to consent by
representation in article 9.3.c states that, “when the minor patient is not intellectually
or emotionally capable of understanding the scope of the intervention. In this case,
consent will be given by the legal representative of the minor after the minor’s opinion
has been heard, if he is over twelve years old."
When this is applied to paediatricians and doctors in general, it means that when they
attend to a minor patient who is capable of understanding the scope, purpose and
nature of the health intervention, he must be considered fully empowered to provide
consent himself. Therefore, it will be the doctor who is responsible for verifying and
confirming if the minor meets the necessary maturity conditions or if he requires the
consent of his legal representatives. It is necessary to highlight that the maturity
required (comprehension and volitional capacity) does not have to be the same for all
medical acts as, in some cases, the complexity of the act makes it necessary for greater
patient understanding and judgment.
But the issue does not finish there as article 9.3.c continues, indicating: “in the case of
actions with a serious risk, according to the criteria of the physician, the minor’s parents
will be informed and their opinion will be taken into consideration in the corresponding
235
decision making process.” This precept once again places the doctor in a position of
great legal and deontological responsibility, that of assessing the specific patient’s
capacity for comprehension regarding the medical act to be carried out when the act
implies a serious risk.
Therefore, it must be understood that when one refers to a “mature minor,” the
intervention of legal representatives in decision making processes must be limited to
scenarios in which the minor himself authorises it. It would be a different scenario if the
minor lacked or had a limited capacity to comprehend and understand the scope of the
intervention and its risks; in this case, consent would undoubtedly be required from his
legal representatives.
Law 41/20002 is clear that when the minor has turned 16, consent by representation is
no longer valid in what could be called usual healthcare, with the actions and
participation of parents being reserved for cases of interventions with serious risks and
other exceptional circumstances (article 9.3c).
Even still, the legal aspects of healthcare for the minor sometimes result in situations
that are difficult to resolve. With this declaration, it is hoped that some guidelines that
facilitate ethical and deontological decisions in paediatricians and doctors in general,
once the clinical and legal judgment of the case has been undertaken, will be provided.
III. Practical recommendations
Chronological age and legal recognition of the rights of minors.
Medical practise establishes three different situations, for which the age of the minor
and his corresponding degree of capacity is set as dividing criteria.
1. Minors under 12 years old.
In general, they do not possess the recognised intellectual or emotional capacity to
understand the scope of the medical act. In these circumstances, consent must always
be given by the minor’s legal representative.
Law 41/2002 indicates that it will be necessary to listen to the opinion of the minor who
is over 12 years old, although consent must be given by his legal representatives.
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The Convention on the Rights of the Child and Organic Law 1/1996 on Legal Protection
of the Minor indicate that it is necessary to listen to the minor when he is younger than
12 years old and, when he is over 12 years old, in addition to listening to his opinion, it
must be considered. However, the final decision will be taken by his legal
representatives and must always be in accordance with the interests of the minor and
respect for his personal dignity.
2. Minors between 12 and 16 years old
This group is undoubtedly the most controversial. As it is so extensive, it may be
subdivided into another two groups simply for care purposes.
On the one hand, when the minor’s intellectual and emotional capacity to understand
the scope of the medical act is not clearly established. This implies the need for consent
to be granted by the minor’s legal representative, although the minor’s opinion must be
heard.
On the other hand, when the minor is intellectually and emotionally capable of
understanding the scope of the care act, and due to what has been mentioned before,
the minor may decide for himself, which poses some questions of a practical nature.
a) When can we confirm that the minor is capable of intellectually and
emotionally understanding the medical act?
b) Is the paediatrician or doctor of another speciality who is responsible for
the care process the person who must determine this?
Previously it was indicated that the legal guidelines are precise and demanding,
however, the laws must be applicable to everyone and, therefore, general. This leads to
practical situations that are always specific, certain, individual and personal in their
characteristics and circumstances. As such, healthcare laws always grant the doctor the
scientific and moral responsibility of assessing and determining the capacity of the
minor to decide.
In looking for security, some doctors defend the need to perform protocols of
consensus, which objectively evaluate the capacity of minor patients.
237
A majority of people believe that the determination of said capacity corresponds to the
doctors responsible for the care process (Declaration of the CCD of 14 November 2014),
and that they must assume responsibility for this scientific, ethical and deontological act
by preparing for it and considering that with it they become a different element to the
parties (parents and children) involved and they enjoy a privileged aspect by acting as
guarantors for minors against the discrepancies between parents and children and,
even, between parents themselves.
Following this criteria, the determination of the capacity of the minor to intellectually
and emotionally understand the scope of the medical act will never be strict: it will vary
according to certain factors, such as the age of the minor, his level of education, his
intellectual level, his life experience, the seriousness of the act to be undertaken, its
complexity, the risk/benefit ratio of the proposed act, and even if the case is urgent or a
medical emergency.
Inherent to the high moral and social responsibility of the doctor, a situation may arise
which the doctor must manage using his legal, ethical and deontological knowledge,
making decisions by using reflection and after having assessed the pros and cons of
every possibility.
If the doctor is the person who must assume responsibility for the delicate task of
determining the capacity of the minor, responsibility for the decision he adopts will also
fall on him. In the event of legal conflict, the doctor must always be in a condition to
explain and reason the basis for the decision taken.
In order to avoid conflicts and address the content of the law, it is advisable that, when
the doctor considers the minor to be mature, his consent to low-risk and common
medical acts is sufficient. His action must be more demanding when, in the pathology of
the minor and the treatment required, seriousness or a significant or important risk is
detected. Likewise, this is the case in requests for services that endanger the life of the
minor patient or his integrity, or when the practise of the medical act is essential or has
irreversible consequences. In this case, it is advisable that the parents of the minor are
informed and their opinion is given regarding the treatment.
In the event of conflict or disagreement between the minor and his parents, or between
both parents, the doctor may turn to civil law (article 163 of the Civil Code), making a
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judge aware of the matter so the attorney general may intervene or a legal defendant is
named for the minor.
3. Minors between 16 and 18 years old
Law 41/2002 highlights that in healthcare consent by representation is not valid in
minors who are over 16 years old. This can be named “health emancipation,” which is
wrongly known by some as “legal age in health.”
Once the minor has turned 16, it is understood that the patient is legalised and of
sufficient capacity to understand and comprehend the medical act in its entirety,
referring to its nature, the risks, the consequences and the purpose of the act,
therefore, the minor would be prepared to give valid consent.
In this regard, the law requires special consideration in “high risk” situations, according
to medical criteria. In these cases, parents will be informed and their opinion will be
taken into consideration for the subsequent decision making process.
However, the “serious risk” does not have to invalidate the consent granted by the
minor, which was based on the degree of maturity and his capacity to understand and
consent to the medical act that is suggested to him.
Consent by representation (parents and/or legal representatives) must be resorted to
when the minor, who is over 16 years old, is found in a situation of (permanent) legal
incapacity or in a situation of presumed incapacity (even if it is of a temporary nature).
Cases of conflict may require the intervention of a judge.
239
IV. Deontological regulation
The 2011 Code of Ethics and Medical Deontology includes, in chapter III on “Relations
between the Doctor and his Patients,” specific guidelines that regulate the status of the
minor.
Article 14
1. An individual over 16 years old is considered qualified to make decisions
regarding ordinary care actions.
2. The opinion of a minor younger than 16 years old will be more or less decisive
according to his age and degree of maturity; this assessment implies the ethical
responsibility of the doctor.
3. In the event of interventions with a high risk to the health of the minor under 16
years old, the doctor is always obliged to inform the minor’s parents and obtain
their consent. Regarding individuals between 16 and 18 years old, their parents
will be informed and their opinion will be considered.
4. When legal representatives make a decision, at the discretion of the doctor, and
if it is contrary to the interests of the person represented, the doctor will request
legal intervention.
The CCD indicates that minors experience illness, pain, fear and anxiety in their own way
and the doctor may not act while ignoring this reality; explanations must be made on
their level so they understand what is happening, and they should be provided with
hopeful responses. The minor must feel accompanied and have security that he will be
helped to overcome the problem; it is not uncommon in practise for doctors to receive
lessons in strength, encouragement and hope from sick minors.
V. Care situations that deserve special consideration
Having expressed the general issues, two situations which, in practise, may be the
source of conflicts for doctors who provide care to minor patients are analysed.
Although these are specific situations, all that the Civil Code states as rights and
obligations of parents regarding their children is applicable, specifying parental rights
and duties, custody and guardianship.
Article 154 of the Civil Code establishes that parental rights and duties will always be
exercised for the benefit of children in accordance with their personality and with
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respect for their physical and psychological integrity. This power if comprised of the
following duties and abilities: watching over them, accompanying them, feeding them,
educating them, representing them and managing their assets.
Article 156 states that:
"Parental rights and duties will be exercised collectively by both parents or by only one
with the express or implied consent of the other. Acts performed by one/both of them
will be valid, in accordance with social use and the circumstances or in situations of
urgent need.
In the event of disagreement, either of the two will be able to turn to a judge who, after
hearing both of them and the child, if he is of sufficient judgement and, in any case, if he
is over twelve years old, will attribute without appeal the ability to decide to the father
or the mother. If the disagreements were reiterated or were to coincide with any other
cause that seriously hinders the exercising of parental rights and duties the judge will be
able to fully or partially attribute this ability to one of the parents or distribute its
functions between them. This measure will be applicable for a set time frame, which may
not exceed two years.
In the scenarios mentioned in the previous paragraphs, regarding third parties acting in
good faith, it will be presumed that each parent acts in the ordinary exercising of
parental rights and duties with the consent of the other.
In the absence, incapacity or impossibility of one of the parents, parental rights and
duties will be exercised exclusively by the other.
If the parents are separated, parental rights and duties will be exercised by the parent
with whom the child lives. However, the judge, at the legitimate request of the other
parent, will be able to, in the interests of the child, attribute the applicant with parental
rights and duties so he may exercise these together with the other parent, or the judge
will be able to distribute the tasks inherent to their exercising between the father and
the mother."
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These provisions apply to the following situations:
A) Medical care for minors with separated parents
Even in these cases, basic regulation cannot be forgotten. All medical decisions
should be based on basic regulation and this is what determines that the superior
interests of the minor must always prevail over any other legitimate interests. This
is the conclusion that can be drawn from the three main laws that govern this kind
of relations: Law 41/2002, of 14 November, on Patient Autonomy and Rights and
Obligations regarding Clinical Information and Documentation, Organic Law
15/1999, of 13 December, on Data Protection, and Organic Law 1/1996, of 15
January, on Legal Protection of the Minor, partially amending the Civil Code and
the Criminal Procedure Law and article 156 of the Civil Code.
In the exercising of parental rights and duties in cases of separated parents, and
with regards to minors, it is necessary to distinguish between ordinary acts and
extraordinary acts.
Ordinary acts could include taking a minor to a consultation with a paediatrician
for a routine check or even banal process. In this situation, the decision will be
made by the parent, whether this is the parent with whom the minor lives or the
parent who is attending the consultation, and it will not be necessary to obtain the
consent of the absent parent in order to undertake the treatment suggested by
the doctor: it will be sufficient for the parent who is accompanying the minor to
grant consent.
This conclusion is drawn from the previously cited article 156 of the Civil Code
when it states that “acts undertaken by one of the parents with parental rights
and duties will be valid, even in the absence of the other parent, when said act is
in accordance with social use and the circumstances."
With regards to extraordinary acts and respect for the health of the minor
(surgical interventions or the application of complex treatments), the agreement
of both parents is necessary.
242
In the event of an emergency situation in which it is not possible to wait to obtain
the consent of both parents, the general principles will be applied, which means
the interest of the minor prevails, with the intervention appropriate to the lex artis
ad hoc being consequently applied, even if one or both parents have expressed an
opposing opinion, with a record of the need for the medical action being made in
the clinical history.
In the event a disagreement exists between both parents regarding the decision to
be made, the matter will be heard in court and the parent who requests or deems
the particular medical intervention necessary or advisable must use this channel.
The judge will be the person responsible for deciding to apply article 156 of the
Civil Code, as when the parents of a minor oppose a treatment and place the
minor’s life or health in danger, the doctor must inform the corresponding judge
of this situation. This happens when it is a problem related to mental health and
psychiatric treatment is recommended, with the law specifying that the
hospitalisation of a minor, in a mental health centre, requires prior legal
authorisation.
This procedure equates to what must be followed when the hospitalisation of an
individual due to psychological health reasons is suggested and the patient
opposes said hospitalisation (article 763 of the Criminal Procedure Law).
However, these situations are not exclusively limited to cases in which
discrepancies between parents exist when making decisions related to a certain
treatment for the minor: they also extend to the right to information regarding the
health status of the minor.
In these cases, the doctor must request verification that the parent or parents that
request the documentation are holders of parental rights and duties as, if this
right has been legally withdrawn from one of them, said parent will not be able to
access the clinical documentation of the minor who is their child.
B) Medical care for emancipated minors
The Civil Code in Chapter XI regulates emancipation, which may be undertaken
due to different causes.
243
By paternal concession. This situation occurs when the parents consider it
appropriate to grant their child, who is a minor, the status of emancipated, an act
that must be set out in public writing or by appearing before the judge responsible
for the Civil Registry (article 317). The minor must be at least 16 years old and his
consent to emancipation must be given.
By legal concession. A situation that occurs in cases in which minors, having turned
16 years old, head to the judge and request the concession of emancipation,
whether they are subject to parental rights and duties or guardianship.
By marriage. By virtue of article 316, “marriage produces the right to
emancipation” without the need for the concurrence of any complementary
requirement.
By independent life. Article 319 establishes that “a child who is over sixteen years
old and who has the consent of his parents to live independently to them is
considered for all intents and purposes as emancipated.” The distinguishing aspect
of said type of emancipation resides in the fact the independent situation of the
minor is revocable. Independence requires at least certain economic autonomy of
the minor, without living separately from the family to which he belongs being
decisive.
In relation to the care of these patients and following the criteria highlighted by
Law 41/2002, a comparison is made between emancipated minors and minors
who are over 16 years old. Only in cases of marriage as a cause of emancipation,
with the minor being over 14 years old, may any kind of conflict be generated, and
this would be easily resolved when it is understood that the minor has a previously
recognised capacity similar to that required to consent to a certain medical action.
Madrid, 31 January 2015
244
Central de Deontología of the
de España on the “Restraint of
Patients”
245
DECLARATION OF THE COMISIÓN CENTRAL DE
DEONTOLOGÍA OF THE ORGANIZACIÓN MÉDICA COLEGIAL
DE ESPAÑA ON THE “RESTRAINT OF PATIENTS”
The Plenary Session of the Comisión Central de Deontología, Derecho Médico y Visado
(Central Commission for Deontology, Medical Law and Endorsement, hereinafter CCD),
hosted on 20 and 21 March 2015, has drawn up this Declaration on the “RESTRAINT OF
PATIENTS."
1. INTRODUCTION
Restraint implies, from an ethical point of view, a confrontation between the principles
of autonomy (limitation of the patient’s freedom against his wishes) and beneficence
(desire to protect the patient, his surrounding area and physical self-protection of
health personnel when their own safety is compromised).
This ethical conflict, which is intrinsically significant, combines with the undoubted risks
that may affect the principle of non-maleficence, as it implies the restriction and
immobilisation of patients, with the possibility of injuries of a different nature. Its legal
implications demand the existence of procedures and regulations that consider the
suitability of prescription, as well as its correct application, and knowledge among the
team of staff involved of the obligation of informing the family or legal representative of
the patient about the process.
In 2009, the Joint Commission on Accreditation of Healthcare Organisations defined
restraint as a “consistent therapy in the suppression of every possibility of movement of
a part or the whole body in order to favour recovery, which is used in psychomotor
agitation or in the lack of control of impulses.”
In our opinion, it is a collection of preventive, therapeutic and care measures that limit
or prevent the mobility of part of the body or the whole body. Their purpose is the
security and protection of the patient who suffers from psychomotor agitation or who is
not capable of voluntarily controlling his movements, which may result in harm to
himself or other people, circumstances that these measures try to prevent and avoid.
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Restraint is characterised as such:
•
•
•
•
•
•
•
•
•
•
It is a therapeutic measure
It is suggested by the doctor
Nursing staff usually apply it
It is resorted to for the protection of the life and safety of the patient himself
and others around him
It entails immobilisation measures of part or all of the body
Instruction is linked to a transitory or maintained state of psychomotor
agitation, uncontrollable impulses, or obvious and serious risk of the patient
falling (from a bed, chair, etc.).
It is always done for the benefit of the patient and as a lesser evil, with the idea
that it will be necessary for the shortest duration possible and it will limit the
freedom of the patient in the smallest degree possible.
It will never be justifiable for the comfort and better rest of health staff or
carers
Respect for the patient’s right to freedom and his dignity will always be
considered and fulfilled as far as possible
This measure is usually applied against the wishes of the patient or, at least
without his effective authorisation.
In light of the aforementioned, it is considered that these measures must be protocolled
regarding:
•
•
•
Their proposal
Their form and procedure
The staff who use them must really understand the measures, their proposal,
risks and benefits, and they must be trained in their application.
II. SITUATIONS OF APPLICATION
1. Post-surgery care (often in intensive care units). In these situations, there is a risk of a
drip being removed, falling off the bed, not maintaining the motionlessness that the
instrumental measures (ventilator, etc.) in place require.
2. Agitated behaviour with impulsive, uncontrolled, sloppy movements that cannot be
controlled via medically assessed and suggested pharmacological procedures. These
may be the result of transitory illnesses or pathologies such as symptoms of agitation
or confused states.
3. Risk of falling from the bed, stretcher or wheelchair despite the restraints on the bed,
stretcher or wheelchair itself. In these situations, if the patient can freely decide when
to place himself within or withdraw himself from these restraints they will not be
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considered “restraint measures” but if they are used against the wishes of the patient
and he cannot remove them then they will be considered “restraint measures.”
III. FEATURES OF RESTRAINT
The application of restraint measures must be subject to the traditional medical, legal,
ethical and deontological process that proposes:
A. Clinical judgement, in which the symptoms and their treatment is identified. When
confusion, agitation, a lack of behavioural control, etc. present themselves as
symptoms, the care team must assess the best way to avoid these symptoms that
act against the safety of the patient, with it being at this point when restraint
measures may be applied.
B. Medical and legal judgement: This requires consideration for the patient’s right to
autonomy and to decide regarding himself and his situation and which measures
would be most favourable to him. If the patient is not in a condition to make a valid
decision, as his capacity to decide is affected, doctors should adopt the measure
that is most favourable to the patient but with the authorisation of the family
member responsible or legal representative, making a note of this in the clinical
history and assessing when it will be necessary to inform a judge of this situation to
make him aware and to enable his supervision.
C. Ethical and deontological judgement: This is a superior level requirement such that
the situation of the patient who requires restraint measures is assessed.
Customisation or specification will be necessary, although decisions are made in
accordance with general protocol, in order to ensure this protocol is applied to the
specific patient and his personal needs.
On this basis, the following is necessary:
1. The measures must be well known by the professionals who propose them
and apply them.
2. The possible undesired effects that may occur must be understood. The
possible risk of asphyxiation due to compression and other serious
situations must also be assessed with great precision.
3. Staff who are authorised to use restraints will be well trained in how to do
so while minimising risks as far as possible.
4. If restraints are used in an emergency situation, the prescription of a doctor
is not required although he will reassess the measure as quickly as possible.
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5. The patient who is subjected to restraints must enter into a protocol of
specific supervision of the measures to evaluate the effects of it on a local
and general level. Other aspects should also be assessed, regarding which
the person makes decisions when he maintains his freedom of movement in
bathroom needs, physiological needs, etc. The safety of the patient may
even indicate monitoring.
IV. CARE SPACES IN WHICH RESTRAINT MEASURES MAY BE PROPOSED
Intensive care units. These patients are subject to extraordinary care and measures and
they undergo close and continuous observation within which restraint measures are
included. In these units, staff are often “on watch” and there is no such thing as a break
while on shift. This offers greater guarantees to supervision, monitoring and observation. It
is also common for these patients to receive a more intensive pharmacological approach
that includes sedation measures, along with other more specific treatments, which means
pharmacology often makes restraint unnecessary.
1. Psychiatric units. In these units, the decision regarding restraints must be subject to
the medical, legal, ethical and deontological process mentioned previously. These
patients are occasionally in situations of compulsory hospitalisation, with this
therapeutic measure falling under the non-voluntary or compulsory concept. The
fact that it is an imposed measures means it must be governed by the principle of
beneficence and the best alternative for the patient at that time.
2. Geriatric units. In these centres, people with diminished autonomy are the most
vulnerable individuals. The care structure of geriatric residences (numerous
residents and sometimes insufficient care staff) favours risk situations where the
use of restraints is not always sufficiently justified.
3. Vulnerable patient units such as centres for minors or detainees. The risk may be in
the use of these measures which are linked to others, such as isolation with the
intention of punishment, not security and benefit for the patient. This is absolutely
rejected by law and medical ethics. No health professional must collaborate in
these measures without medical instruction and the aforementioned purpose.
4. Emergency services. These usually see a variety of patients (intoxications,
withdrawal symptoms, confused states, etc.) and situations that, in their initial
stages, make this measure necessary as a prevention or specific treatment option.
5. In the home. This usually involves older people or people affected by neurological,
degenerative or mental illness who are in the care of family members or carers, and
to whom restraint measures may apply without real medical justification.
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V. MEDICAL, LEGAL, ETHICAL AND DEONTOLOGICAL GUIDELINES
A. There are numerous protocols regarding restraint drawn up by health centres and
scientific organisations. These protocols include a clinical decision tree with the
steps prior to these measures, such as speech and pharmacology. They also include
an instruction form and even communication to the judge, making this measure
similar to compulsory or involuntary hospitalisation. With regards to this, it is
essential that, where restraint is used, an application protocol that is agreed to by
the staff participating in the process has been adopted.
B. Respect for patient autonomy must be performed as far as possible in the
application of restraint measures. In this regard, it is appropriate to anticipate the
need to use these measures such that patients may be informed of their possible
use. As such, the duty of informing will be fulfilled and the wish of the patient will
be expressed. This may occur in patients with mental disorders, neurological or
degenerative disorders, or even in older patients. In these cases, taking advantage
of the fact that advanced deterioration or periods of improvement have not
occurred enables them to participate in the possible use of these measures in the
event that, in the future, they may be required. This would be an expression of
advance directives regarding this therapeutic measure, within the more general
planning of future care measures. In fact, in advance directives or advance
instructions it would be advisable to include these measures so that the person,
who is currently healthy, expresses his desires, understanding their benefit.
C. It is a therapeutic measure that must be established by a doctor, although it is
normally nursing staff who apply it. If it is applied as an emergency measure, a
doctor must ratify it in a short space of time.
D. It is necessary for staff to accept it as a therapeutic measure against a scale of
protective measures that have already been tried and proven to be inefficient.
These staff members must be trained in how to apply restraint measures, they
must know the risks and benefits of each of them, and they must understand the
need to supervise the patient who is immobilised, evaluating the possible local and
general effects of each measure.
E. The duration of restraint must be as short as possible.
F. In no case will restraint be applied to favour staff breaks, nor may it be justified by
the lack of care staff.
Madrid, 25 April 2015
250
The Figure of the Responsible
Doctor
251
The General Assembly of the Consejo General de Colegios Oficiales de Médicos de
España (General Council for Official Medical Associations in Spain, or CGCOM), hosted on
14 November 2014, adopted the agreement to approve the following declaration drawn up
by the Comisión Central de Deontología, Derecho Médico y Visado (Central Commission for
Deontology, Medical and Endorsement) of the CGCOM:
THE FIGURE OF THE RESPONSIBLE DOCTOR
INTRODUCTION
To be a doctor is to exercise a profession that depends, in part, on a good
interpersonal relationship as its objective is to attend to people when they feel or
experience a health problem that makes them anxious, and which results in them turning
to another person who they believe has sufficient knowledge to achieve the goal of reestablishing their health. Therefore, the doctor-patient relationship arises, which, among
other things, acts as one of the most universal and powerful “drugs” and which must not
be lost, for the common good. The doctor-patient relationship is a personal relationship
with all of the virtues and defects of a relationship between people. This relationship is
undoubtedly based on the scientific and technical knowledge of the doctor, but also on the
hope and trust the patient has in the doctor, which may deteriorate without a good
relationship, therefore underlining the importance of information, an aspect that the
professional may not hold in as high regard as he may pay more attention to diagnosis and
be more concerned with reaching a correct therapeutic decision.
The doctor-patient relationship is complex. The socialisation of medicine is positive,
given that, among other things, it has placed technological advancements within the reach
of everyone. However, it has upset the doctor-patient relationship, at least in part, as it
was personal and trusting a few years ago (sometimes with a paternalistic aspect) and it
has become a relationship in which the patient frequently sees the doctor as a civil servant
who represents the managing organisation.
Furthermore, technological advancements and large health institutions (especially
hospitals) have determined that patients, who are usually visited by several doctors,
cannot define who is really “their doctor,” in other words, they cannot identify the “doctor
who is responsible” (RD) for his care, meaning a true and appropriate doctor-patient
relationship cannot be established.
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DEFINITION
In order to define the figure of the RD, it is appropriate to quote Law 41/2002, of 14
November, on Patient Autonomy and Rights and Obligations regarding Clinical Information
and Documentation, as it outlines the RD, in article 3, as “the professional who is
responsible for coordinating the health information and care of the patient or user, in the
role of main spokesperson for this in every relation to care and information throughout the
care process, without prejudice to the obligations of the other professionals who
participate in care actions.”
For years, legislation has established that all patients have the right to “be assigned
a doctor, whose name will be given, and who will be the main spokesperson for the care
team. In his absence, another physician from the team will assume this responsibility,” as
stated in article 10.7 of General Health Law 14/1986, of 25 April (hereinafter LGS, to use its
Spanish term). Furthermore, in article 4.3, it indicates that “the doctor responsible for the
patient guarantees him the fulfilment of his right to information. The professionals who
attend to him throughout the care process or apply a specific technique or procedure will
also be responsible for informing him.”
The RD is, in current legislation, a figure within the health system who is entrusted
with a series of specific functions that are clearly included within professional medical
competency, in addition to others that are removed from his strict competency and which
convert the RD into the guarantor for a series of issues and even decisions that transcend
what is specifically asked of a medical professional.
In this regard, the LGS, in article 3, indicates that the RD is the professional who is
charged with “coordinating the health information and care of the patient or user, in the
role of main spokesperson for this in every relation to care and information throughout the
care process, without prejudice to the obligations of the other professionals who
participate in care actions.”
In articles 3, 4 and 5 of Law 41/2002, of 14 November, on Patient Autonomy and
Rights and Obligations regarding Clinical Information and Documentation, the RD and his
obligations are described in several senses:
•
•
•
As the coordinator of information that must be conveyed to the patient and his family.
As the person responsible and the visible head of the medical care team.
And in reference to care information, where the RD guarantees the fulfilment of his
right to information, as mentioned in the previous definition.
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Article 5 referred to the “Owner of the right to care information,” and, in section 3,
it indicates that when the patient, according to the criteria of the doctor who attends to
him (it does not expressly refer to the RD, instead, any doctor on the team), does not have
the capacity to understand the information due to his physical or psychological state, the
information will be conveyed to people linked to him by family or legal relationship.
However, article 9 on “Limits of informed consent and consent by representation,” in
section 3, highlights that consent by representation must be performed “when the patient
is incapable of making decisions, according to the criteria of the doctor responsible for
care, or if his physical or psychological state does not enable him to take control of his
situation. If the patient lacks a legal representative, consent will be given by the people
linked to him.” Although the law does not specify that situations of incapacity, which are
different to physical and psychological incapacity, it refers to and may be differentiated to
those highlighted in article 9 where it states that the patient is incapable of making
decisions according to the criteria of the RD.
Therefore, the law does not precisely delimit which doctor responsible must make
the decision that a certain patient lacks the capacity to understand the information and,
therefore, the doctor must know who to inform and address for consent. As such,
consideration of the obligatory nature that the law addresses (“when the patient is
incapable of making decisions, according to the criteria of the doctor responsible for care”)
can be suggested when this decision, whether it is difficult or conflicting, could at least be
shared by a representative organisation such as the Comité de Ética Asistencial (Care Ethics
Committee, or the CEA).
Furthermore, in the section about the “end of medical leave report,” it is specified
that this is the document issued by the RD when each patient care process is completed
and it notes that this document must include a summary of the clinical history, the care
activity provided, the diagnosis and finally the therapeutic recommendations. Occasionally
the patient may only know his RD when he receives the signed “end of medical leave
report.”
Having said that, in all aspects the RD is considered the main, although not
exclusive, guarantor of the patient inasmuch as this does not exempt the other
professionals who are involved in the care process from the care and legal obligations, thus
avoiding possible problems of unique responsibility in his actions.
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When these precepts and concepts are transferred to usual clinical practise, it is
deemed opportune to state the following assessments in the form of a summary:
•
Currently, due to diverse factors, especially the modernisation and specialisation of
medicine and the legal and deontological requirements of the doctor, with regards
to medical information and other patient rights comprised in his care, the figure of
the RD is of imperative importance.
•
In primary care, which is characterised by a closer relationship with the patient, it is
normal for a doctor to personally know his patients and act as a guide for them in
any matter related to information and care.
•
In hospital medicine, which is characterised by a greater structural and
organisational complexity, the doctor-patient relationship is even vaguer as it is
developed by a multidisciplinary medical team, which hinders care information. In
this sense, a patient may be seen in successive consultations by different doctors,
from the same or different teams, or he may head to the operating theatre for an
intervention without having previously enjoyed the advisable relationship with the
surgeon who will be operating on him. To this, one can add the thankfully rare fact
that the patient may not be seen during the post-operative period by the surgeon
who operated on him, due to the structuring of the work of surgical hospital
services.
•
From the aforementioned it can be concluded that in some cases, either the patient
or his family members may not have a clear individual whom they may address to
gather information during the hospitalisation process; someone with whom they
can maintain a continued relationship during the care process and who will keep
them informed.
•
One must be aware that the figure of the RD does not necessarily have to be the
same person throughout the care process but the patient must know, at all times,
who is his RD. This aspect must be paid particular attention when the patient is
transferred to another service, for example, from a medical service to a surgical or
oncological service. As well as transferring the clinical history, the patient must be
informed as to who will be his surgeon or oncologist who is responsible for his care,
in short, his new RD.
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ETHICAL AND DEONTOLOGICAL CONSIDERATIONS
•
The figure of the RD is key in all aspects of the healthcare received and the
informing of a patient and his family members. The RD must be the visible head of
the care team for the patient and the family. The RD is the person in whom patients
trust, with whom they wish to speak and by whom they preferably wish to be
informed in the majority of occasions.
•
Furthermore, the figure of the RD is also key as a guarantor for patient rights in
aspects that are as important as the patient’s capacity to make decisions or
understand the information that must be given to him, as well as the preservation
of confidentiality and privacy.
•
The Code of Ethics and Medical Deontology establishes:
Article 10: An essential aspect in the provision of information is making the patient
or his close family aware of the identity of the doctor responsible for his care
process, in addition to that of the person who will be providing care at any given
moment.
Article 16.1: Informing the patient is not a bureaucratic act, it is a clinical act.
Responsibility for it should be assumed directly by the doctor responsible for the
care process after reaching a precise clinical judgement.
•
In the Organización Médica Colegial de España (Spanish Collegiate Medical
Association)’s manual on “The good work of the doctor,” in area 4, section 65, on
“Communication and collaboration,” it establishes that “The doctor will do
everything possible to correctly and intelligibly inform patients, sharing with them
the information they need to make the best decisions regarding their care,
including:
o Their health status, their anticipated development and the possible
treatments available, in addition to the potential risks and uncertainties.
o The development of their care, and the role and responsibility of each
doctor on the care team.
o The name of the person who is responsible for the diverse aspects of
patient care, how information is shared within health teams and
between staff who are charged with attending to the patient.”
256
In other words, this section indicates the obligation of every doctor who attends to
a patient to inform him as to who is the RD.
CONCLUSIONS
1. The existence of the figure of the responsible doctor is an ethical, deontological and legal
mandate.
2. The figure of the responsible doctor guarantees a suitable customisation and
humanisation of care. This figure must be promoted as it signifies, for patients, easy and
trusted access to information on the care they are receiving.
3. The figure of the responsible doctor facilitates and guarantees the effective fulfilment of
the significant clinical act of informing and it has also been shown to improve the quality
perceived by patients in the medical care they receive.
4. The people responsible for managing care teams must ensure the effective fulfilment of
this ethically, deontologically and legally important precept by promoting and facilitating
the presence of the responsible doctor from the outset of each care process and his
effective recognition by patients.
5. These aspects are relevant in all areas of medicine but especially in hospital care.
257
258
Central de Deontología on
Conscientious Objection
259
DECLARATION OF THE COMISION CENTRAL
DEONTOLOGÍA ON CONSCIENTIOUS OBJECTION
DE
Introduction
Conscientious objection (CO) in medicine arises from the conflict that occurs when there
is a clash between the moral duty of a professional in following the dictates of his
conscience and the legal duty that this professional must provide certain care. It is a very
topical issue and is considered in many circumstances to be due to the ever greater
ethical pluralism of society and the significant changes that have occurred in recent
decades in the way medicine is practised by the hand of genetic therapy and artificial
fertilisation treatments.
CO is not expressly regulated in the deontological code. It is mentioned in some articles
but it is addressed in an incomplete manner. As such, the Comisión Central de
Deontología (Central Commission for Deontology) has deemed it convenient to offer all
collegiate members this Declaration to complete deontological learning in this regard,
guide the conduct of doctors and transfer this information to society.
Conceptual delimitation and legal justification
1. CO is a form of resistance to the right that is conditioned by the impossibility of obeying
a law, regulation, ruling or order based on the moral convictions of a person. It is, in
short, the individual refusal to subject oneself, due to reasons of conscience, to a
medical act that, in principle, would be legally required. It differs to civil disobedience
as it accepts the reprimand that non-fulfilment of the guideline may result in for the
offender. Civil disobedience hopes to repeal this guideline and is usually a behaviour of
a collective nature or one with political arguments. Meanwhile, CO is an individual
behaviour based on moral or religious assumptions, in which the objector does not
hope to repeal the guideline with which he has not complied, but merely hopes to
avoid reprimand for trying to preserve the ruling of his conscience by failing to fulfil the
guideline.
2. Although CO is not expressly regulated except for in military service (article 30.2 of the
Spanish Constitution), there is jurisprudence related to its exercising by doctors,
essentially in cases of abortion. This jurisprudence is not unanimous and in some
aspects it is contradictory, which has caused no end of problems in terms of legal
260
insecurity. Ruling 53/1985 of the Constitutional Court (CC), in its legal basis (LB) 14
explains that the right to CO “exists and may be exercised with independence of what is
dictated in said regulation,” given that “conscientious objection forms a part of the
essential content of the ideological and religious freedom recognised in article 16.1 of
the Constitution.” However, the same High Court, in LB 2 of its ruling 160/87 confirms
that CO only is legitimate in the measure in which article 30.2 of the Spanish
Constitution establishes it as “without this recognition, the right may not be exercised,
not even under the protection of ideological or conscientious freedom that, in itself,
would not be sufficient to liberate citizens from their constitutional or ‘subconstitutional’ duties due to reasons of conscience.” Ruling 161/87 from the same High
Court is more emphatic in its LB 3: “conscientious objection of a general nature,
meaning the right to exemption from fulfilling constitutional or legal duties against
one’s own convictions, is not recognised and has never been considered in our law or in
any law, as it would signify the negation of the concept of the State.” However, it
admits that “what may happen is that it is admitted exceptionally for a specific duty.”
Despite this jurisprudence, today there is extensive agreement in considering the right
to CO as an autonomous, individual and fundamental constitutional right; as a generic
declaration of the individual’s right to freedom of conscience, stated in article 16.1 of
the Constitution. CO implies a specification of said right when the subject comes into
conflict with legal rights contrary to this specification.
Current deontological guidelines
1. The World Medical Association’s Oslo Declaration on Abortion (Oslo 1970) and its
successive revisions up to the latest at Pilanesberg (South Africa) in 2006 establishes, in
point 6, “If the convictions of the doctor do not enable him to advise on or carry out an
abortion, he may withdraw, as long as he guarantees that a qualified colleague will
continue to provide medical care.”
2. The European Guide to Medical Ethics, in article 18, states “It is ethically acceptable for
the doctor, due to his personal convictions, to refuse to participate in reproduction
processes or in cases of pregnancy termination or abortions.”
3. The General Assembly of the Consejo General de Colegios Oficiales de Médicos
(General Council for Official Medical Associations), hosted on 31 May 1997, approved
the Comisión Central de Deontología’s Declaration on the Conscientious Objection of
the Doctor, which, in its ethical principles, states “The refusal of the doctor to perform,
due to ethical or religious reasons, certain acts that are ordered or tolerated by the
authority is an action of great ethical dignity when the reasons claimed by the doctor
are serious, sincere and consistent, and they refer to serious and essential issues.”
4. The current Deontological Code mentions the right to CO in several articles:
261
Article 9.3: If the patient were to request a procedure that the doctor, due to scientific
or ethical reasons, deems unsuitable or unacceptable, the doctor, after duly informing
the patient, will remain exempt from acting.
Article 26.1: The doctor has the right to refuse, due to reasons of conscience, to
recommend a method of regulating and assisting reproduction, to performing
sterilisation or to terminating a pregnancy. He will immediately clarify his abstention
and he will offer, if applicable, the appropriate treatment for the problem regarding
which he was consulted. He will always respect the freedom of the people involved to
seek the opinion of other doctors. He must consider that the staff with whom he
collaborates have their own rights and duties.
Article 26.2: The doctor will be able to communicate to the medical association his
stance as conscientious objector for the purposes he deems appropriate, especially if
said stance results in administrative conflicts or conflicts in his professional practise.
The association will provide him with the necessary advice and assistance.
Practical considerations
1. The doctor can and should refuse to perform medical practises that go against the
dictates of his conscience. It is a moral duty and a just practise from a social
perspective.
2. CO in medicine may never imply a discrimination of individuals. The doctor may refuse
an action as it signifies, for him, a serious moral problem, but never due to certain
characteristics of the patient such as age, race, ideology, religion or other similar
aspects.
3. The objecting doctor will communicate his objection to the provision of the specific
service to the patient in a reasonable manner. In any case, he must direct the patient
to the professional or institution that can respond to the requested care need.
4. It is ethically reprehensible for a collegiate member to conscientiously object to a
practise in the institution in which he works as a salaried worker if he practises the
action objected to when he works independently. Such behaviour would be a sign of
moral duplicity that would result in the medical profession suffering a serious loss of
prestige as it would reveal that profit is the main reason for this behaviour.
5. Exercising CO does not exempt the doctor from providing any other medical care,
especially in emergency situations, to the person who has caused his objection, even
if this emergency is related to the activity objected to.
262
6. The objecting doctor must communicate his stance to those responsible for the
institution where he works. He will also communicate it to his professional
association.
7. CO may never signify discrimination of any kind against the doctor who exercises it.
The objecting doctor must never suffer from pressure when carrying out his tasks due
to being an objector. The objecting doctor will never obtain occupational advantages
for his stance and he will willingly accept other tasks that are assigned to him in the
institution for which he works.
8. In medicine today, there may be numerous causes of conscientious objection,
including: voluntary termination of a pregnancy, contraception, therapies with
embryonic mother cells, euthanasia, rejecting and demanding treatments, forced
feeding of hunger strikers. These situations can create serious conflicts of a moral
nature and in daily practise, and they must be addressed with reflection and
calmness.
263
264
Declaration of the
de España on Pharmaceutical
Care
265
DECLARATION OF THE ORGANIZACIÓN MÉDICA COLEGIAL DE
ESPAÑA ON PHARMACEUTICAL CARE
There is growing concern among doctors and several health experts, provoked by
the plan to implement so-called “pharmaceutical care” in the Sistema Nacional de Salud
(National Health System, hereinafter SNS). The Organización Médica Colegial de España
(Spanish Collegiate Medical Association, or OMC), which represents the medical
professions, believes it is necessary to adopt a public stance regarding this matter. As
such, it has drawn up this document in which it explains the reasons for its stance:
1. Pharmaceutical care violates the clinical authority and responsibility that protect
the patient
“Pharmaceutical care” is undermined by a fundamental contradiction that does
not have a solution as, to exercise it, it is essential for the pharmacist to diagnose and
have the clinical history of the patient, named here as the pharmacotherapeutic history,
and establish a “direct interaction” 9 with the patient, in short, a clinical relationship with
the patient. However, the pharmacist is not a clinician, nor can he be one, as he lacks
the knowledge, practical training, practise, social authorisation and legal responsibility,
all of which are necessary aspects in exercising a clinical activity on the patient. The
pharmaceutical profession is designed and prepared for other socio-sanitary tasks; the
cooperative relationship with the doctor may not be expanded, nor may said
competencies be reformed. As such, the patient does not have the capacity to “grant
clinical authority to the pharmacist” 10 either, except for outside scientific medicine and
the SNS.
Only professional training institutions and authorities may establish the
competencies necessary for each profession. Therefore, only the doctor who is qualified
after years of studying and specific practise is a guarantor to society and the patient
when providing a correct clinical activity. “Pharmaceutical care,” which involves an
obvious health risk and clear legal damage, puts the patient in the hands of someone
who is not a doctor and who does not have clinical authorisation or responsibility.
C.D. Heppler and L.M. Strand, ‘Opportunities and responsibilities in pharmaceutical care,’
American Journal Pharmaceutical Association, 1990, 53: 75-155
10
J. Bonal and L. García, ‘¿Atención farmacéutica? 100 preguntas más frecuentes,’ Editores
Médicos S.A., Madrid 2002.
9
266
2. Pharmaceutical care is unnecessary
Pharmaceutical care has presented itself as an instrument in the detection and
reduction of the problems related to medication that occasionally debilitate or nullify
the effects of the pharmacological therapy, ranging from errors in prescription, in
dispensing or in administration to the dispensing of medication that does not require a
medical prescription, intolerances and adverse reactions to medication, among other
functions.
The impact and cost of problems related to drugs – which constitute some of the
structural deficits in a complex health organisation – cannot be determined with due
thoroughness as they are basic data of an uncertain nature in this field 11 and,
consequently, the result of statistical calculations may be dubious and easily
manipulated. On the other hand, there is no proof that “pharmaceutical care” provides
economic advantages regarding a reduction in problems related to drugs or therapeutic
or health benefits for patients.
Whatever the real figure and its significance, problems related to drugs are
undesirable and the SNS must combat these. This is a task that does not require, in any
way, resorting to “pharmaceutical care.”
The OMC believes the preventable problems related to medication require the
fulfilment of training and competence in each of the health agents assigned to this area.
To ensure the doctor, who is responsible for diagnosis and prescription, fulfils these
functions, he must have ideal structural conditions so his practise is undertaken with the
greatest guarantees.
To reduce the problems linked to the use and handling of medicines, the health
education and knowledge of the population is essential and this must include the
beneficial effects of the correct use of medicines as well as the health risks derived from
their inappropriate use. This education would be more effective if it were to promote an
11
“Medical treatment is obviously aimed at those who are sick, but it is often difficult or impossible to
discern if an adverse effect is the consequence of the development of the illness for which patients are
treated or the treatment (prescribed).” The United States General Accounting Office, in a particularly clear
analysis, warns that “the magnitude of the risk to health is uncertain due to the limitations of the impact
data.” (Dr. Robin Esmond Ferrer, Director of the West Midlands Centre for Adverse Reaction Reporting
City Hospital, Birmingham, ‘The primrose path. Errors in prescribing and giving medicines,’ Drug
Information Journal, 2001, 35: 633-9).
267
appropriate doctor-patient relationship that minimises the problems of using medicines.
Likewise, if it were to establish fluid collaboration between doctor and pharmacist in
both the prescription and dispensation of medicines.
Reducing problems related to medicines is related to the quality of care and,
essentially, the factors that determine the quality of the medical act. The OMC believes
it is difficult to avoid problems related to medication in an environment of high pressure
care and one that lacks time and prevents the doctors from performing a thorough
reflection on the patient’s prescription in addition to the risks of the prescription 12.
If the number of doctors is insufficient, the system must hire more doctors. Spain
has made an effort in the training and specialisation of a huge number of doctors which
was not only wasted but which also permitted emigration to numerous other countries
around us when they are required in our own. It would be contradictory if the
occupational difficulty Spanish doctors suffer, due to the poor sizing of staff teams in
relation to the actual demand for care, were used to protect the unqualified practise of
other professionals in the tasks and responsibilities of the doctor.
3. Pharmaceutical care would be a heavy financial burden
It is not possible to estimate the true scope of the problems related to
medication, therefore, nor is it possible to estimate the cost (or saving if they were
decreased). However, it is easy to perceive that the establishment of “pharmaceutical
care” would absorb numerous financial resources of the SNS. Firstly, due to the
investment in the provisioning of 21,000 pharmacies with computing hardware, a
consultation office and the confection and archiving of pharmacotherapeutic (clinical)
histories. Secondly, due to the functioning of computing means, the preparation of
“standard operating procedures” (SOPs), and the remaining administrative labour.
Thirdly, due to the recompense paid to the 21,000 pharmacies, whether the calculation
basis is made per patient or in terms of 40 million Spaniards who hope to be attended;
however, the possibility of performing the calculation through a fixed quantity per
prescription – 650 million dispensed in 2002 – also exists, or a set quantity per pharmacy
could be established, using the payments for Public Home Care pharmacists and even
the mixed payment as a reference.
12
J. Bonal and L. García, op. cit. pp. 25
268
In any case, running costs would be exorbitant and “pharmaceutical care” would
entail an enormous, irreversible and progressive financial burden to the SNS,
comparable to the current cost of the primary care network, without the compensation
being fully known.
Last but not least, “pharmaceutical care” would imply, in practise, a greater
privatisation of the SNS as investment in it and its costs would be allocated to private
establishments. This is in addition to increasing the risks to confidentiality and clinical
data protection, which constitutes a sensitive subject for the population.
In this regard, we advocate the technical development of a communication
infrastructure, based on new technology, between the pharmacy and the primary care
doctor.
4. Pharmaceutical care does not exist anywhere in the world
In reality, “pharmaceutical care” does not exist. Defined for the first time in
1975 , it has still not emerged in health practise in any nation in the world. Therefore, it
remains in a state of “reduced theoretical and experimental nebula in certain
countries.” 14 Following a long 28 years, the idea of “pharmaceutical care” has not been
able to take shape in modern society, which is characterised by its quickness to accept
new products, concepts and services. In other words, in almost three decades no health
system, whether public or private, on any continent, developed or not, has considered
pharmaceutical care useful. This detail is conclusive, and it is astonishing that it is hoped
Spain will be the only exception in the world.
13
At the base of this debate on “pharmaceutical care” there is a lingering conflict
of health subsystems. On the one hand, medical care with a very participatory,
regulated and socialised model, as opposed to the pharmacy which is developed in a
very liberal framework and has aspirations of increasing its scope of application in direct
opposition to the rest of the SNS.
13
4
14
5
J. Bonal and L. García, op. cit. pp. 11
E. Costas, op. cit. pp. 57
269
270
Proposals for a Quality
Prescription
Part II -
271
PROPOSALS FOR A QUALITY PRESCRIPTION – PART II
José A. González Correa, Felipe
Sánchez de la Cuesta
Department
of
Pharmacology, Faculty of
Medicine in Malaga
1
The partial or full reproduction of this document remains prohibited without the express
authorisation of the Consejo General de Colegios Oficiales de Médicos.
272
Factors that influence prescription
Overview of the problem
The pharmacological prescription is an act inherent to the doctor. This act takes
place on a complex stage and is influenced by a series of factors.
The doctor must complete the prescription under significant care pressure while the
majority of patients understand it as the last act of the medical process. This is mainly
based on the misinformation the patient receives due, in the majority of cases, to the
excessive publicity of drugs and news pieces, which are not always corroborated, in the
media.
However, there are other factors that impact prescription, such as the pressure
exercised by the pharmaceutical industry, the conflicting decisions of the administration in
terms of medicines, and interactions with other health professionals.
We understand that the quality prescription must be developed within the concept
of the best use of the medicine on which the doctor establishes his professional practise.
However, a quality prescription and the best use of the medicine may not be assumed only
to name programmes aimed exclusively at the containment of pharmaceutical spending
without contemplating the health impact of its implementation, or without understanding
or evaluating the conditions in which the doctor works daily and which are occasionally
insufficiently assessed.
In short, the doctor works by establishing a relationship with patients, a relationship
that hopes to obtain a suitable state of health or the re-establishment of health,
maintaining the greatest quality of life possible. It should not be forgotten that significant
financial interests are derived from this relationship, and regarding the treatment, for the
health system, the pharmaceutical industry and society in general.
In this regard, there isn’t the slightest doubt that the use of drugs in the treatment
of some illnesses has enabled the doctor to favourably influence the prognosis of patients.
However, at the same time, the introduction to the market of medicines that are ever
more powerful and the extensive and not always appropriate use of these medicines may
generate unfavourable consequences for the health of the population.
273
The existence of extensive pharmacopeia, especially in our country, makes it
necessary to maintain an appropriate and updated level of knowledge among doctors such
that the necessary information and training are reflected in a quality prescription.
Therefore, the information conveyed to the doctor may not be of a punitive nature.
It must be based on clinical proof that has been confirmed and evaluated by the scientific
community. It must avoid contradictions and discrepancies such as the defence of the use
of generic medicines while introducing medicines that have not had their bioequivalence
checked with the model medication to the list of therapeutic options on the computing
programmes of primary care consultations.
It is essential to involve the primary care doctor in the different quality goals and
better use of medicines objectives, implementing the exclusive control measures on costs
developed up to the present day, with measures aimed at: discovering the reality in the
scope of primary care; the informing of health personnel and the training of these staff
members in tasks of developing new therapeutic strategies; the monitoring of the
different, most recently commercialised drugs from a double perspective (efficacy and
safety); the review and control of information and training measures and strategies
developed; and finally, raising awareness, through evidence of the best therapeutic
measure available for a specific patient, of the use of the medication that entails the lowest
cost.
Factors involved
Professional doctor
Training and information
The doctor receives an enormous amount of pharmacotherapeutic information, in
many cases (up to 75%) through the technical informants for the drug, in others (less
frequently) through training courses or seminars. The most notable aspect is the huge
variability regarding the sources and thoroughness of said information. The critical reading
of scientific articles is probably one of the least used measures in the acquisition of the
knowledge required to update medicines.
274
Furthermore, the panorama of the medicines market in our country is infuriating.
Original medicines, licences, copies and generic medication coexist. We find confusing
concepts regarding the interchangeability of medicines, like therapeutic equivalence,
generic specialities, pharmaceutical specialities (within the homogenous groups
established by Royal Decree 1035/1999 on Reference Prices), branded generic specialities,
branded pharmaceutical specialities, chemical equivalents, pharmaceutical equivalents,
etc. As such, the administration is partly responsible as: it enables the registration of new
drugs that do not provide great advantages with regards to other agents within the same
pharmacological group; it approves new indications, covered by other drugs, for medicines
that do not consider these indications; it restricts or prohibits the use of certain drugs in
primary care while it increases their clinical uses; or it uses economic criteria as the basis to
recommending prescription according to active ingredient without considering the efficacy
parameters of new substances that are not subjected to this type of prescription due to a
generic deficiency, which the administration itself approved.
In order to ease the aforementioned, scientific organisations, medical colleges,
pharmaceutical laboratories and other organisations have tried to establish
pharmacotherapeutic guides, which, in many cases, only provide answers to specific
problems or are not readily accessible to primary care doctors.
How can pharmacotherapeutic information be optimised?
Without a doubt, the creation of pharmacotherapeutic and prescription quality
commissions – at a health centre, clinical unit or hospital service level, in which knowledge
and attitudes in relation to the implementation of programmes and the adaptation of
pharmacotherapeutic guides are assessed – could be a solution.
It is interesting, from an organisational perspective, to examine the incorporation of
the clinical pharmacologist in primary care. His participation should be adapted in
accordance with the following objectives (1):
•
•
•
•
•
Pharmacological training and advice
Adaptation of pharmacotherapeutic guides and protocols
Coordination in investigation activities regarding drugs in the scope of primary
care
Assessment of the use of medicines and establishment of quality prescription
criteria
Serve as a link with the hospital in aspects related to research and programmes
275
for the detection of adverse reactions
The therapeutic problem must be reviewed from the prescriber’s point of view,
revising the role of a specific drug, discussing the scientific proof of its practical value
(comparing therapeutic and pharmacological strategies) and presenting conclusions
regarding when, why and how to use a certain treatment.
In this regard, clinical pharmacology is a discipline that combines basic knowledge
and clinical experience for the ultimate purpose of increasing efficacy and safety in the
handling of medicines. Therefore, the prescriber’s therapeutic recommendations are not
exclusively theoretical: in addition to critically analysing the results in pharmacological
research, he knows how to adjust the principles of therapeutics in the specific clinical scope
and situation.
A medical professional with training in clinical pharmacology would play a decisive
role in raising awareness and advising the primary care doctor in this regard. The
undertaking of therapeutic consultations, clinical consultations related to the use of drugs,
and pharmacotherapeutic sessions, would be essential points on the agenda of the clinical
pharmacologist to be carried out with the assigned health centres in which the bases of a
quality prescription in the scope of primary care is supported. The implementation of these
training and information strategies would involve the presence of economic sense linked to
prescription and the doctor’s acceptance of the concept of efficacy, once established
thoroughly and scientific evidence shows the most appropriate pharmacological and
therapeutic attitudes to a specific clinical situation. As such, and having overcome the
doctor’s susceptibility phase, due to the coercive measures used, it will be much easier
with the help of the clinical pharmacologist to accept and employ generic medicines in the
interests of greater efficacy. The containment measures for pharmaceutical spending,
which are considered later, should be based on objective criteria in which the main
purpose is not the measure of saving, but improving prescription and promoting its
efficient use.
These, among others, are the advantages that these professionals can bring to the
rationalisation of the therapeutic option in light of the exclusive monitoring contributed by
other health professionals.
276
Characteristics of the prescription in the scope of primary care
This is an important aspect to be developed given that 90% of prescriptions are
made in the scope of primary care. However, a significant volume of the prescriptions
made by the family doctor are generated by other care levels (specialists and hospital).
According to diverse authors, they can amount to between 18.8 and 30% (2) of the
accepted prescription and this poses frequent problems, as it is not adapted to a previously
agreed guide in primary care. The definition of pharmacotherapeutic protocols and guides
together, which include the most prevalent health problems, solve a large number of these
problems.
Clinical characteristics of patients
Although the clinical characteristics (how many and what illnesses) seem obvious,
they explain a large part of the use of a population’s health resources (measured by
number of visits) and the variability of medical practise (measured by number of diagnostic
tests requested and number of patient referrals to specialists).
In this regard, it is important to note that, from a perspective of rational use,
therapy must be understood in the context of the pathological individuality of a certain
patient, addressing his physiological, pathological and even social circumstances. For
example, the use of angiotensin-converting-enzyme inhibitors (ACE inhibitors) may vary
depending on the pathology for which they are used, pursuing different results variable
from a therapeutic perspective: decrease in arterial tensions, ventricular remodelling,
increased survival rate or improved quality of life, depending on the pathological process at
which they are aimed.
Specifically, the variability in the number of visits made, which is explained by the
pathology the patient presents, is at 50%; or, in other words, half of the visits made by
patients depend directly on their current health problem. We can read more into this: the
doctor debates every day between attending the problems of his patients on the one hand
and, on the other hand, resolving the bureaucratic aspects related to medical care. All of
this occurs in an absolutely insufficient average consultation time per patient, as the
administration knows well and as primary care doctors repeatedly report (3).
277
Attitude of the population towards medication
The medical act of prescribing is clearly influenced by the collective knowledge and
attitudes of the population regarding pharmaceutical products.
The pharmacological prescription has become the act that finalises medical care. It
does not go unnoticed that the majority of patients demand a medicine after being
assessed by their doctor. The doctor’s problems in this regard are significant and worrying
as, when he does not fulfil this patient expectation, it gives rise to a coercive response of
the patient towards the doctor and, in some cases, a violent response. The only solution to
not falling into a situation of compliance regarding the patient is information. From an
ethical point of view, the principle of justice and equality does not make the prescription of
a medicine as an inherent part of the medical act obligatory, moreover, in the interests of
resource optimisation, compliance lacks sense.
Not only should the patient receive the correct information about why, when and
how he should consume the medicine or the non-pharmacological measures he must carry
out, he should also be perfectly informed when the prescription of a medicine is not
considered useful. Only in this way may the doctor-patient relationship become stronger
and therefore contribute to the health education of the patient so he does not seek to
obtain the medicine via other channels (self-medication, induced prescription).
The ethics in this regard defend, in the interests of the principle of autonomy, the
establishment of a therapeutic consensus or alliance between the doctor and the patient.
However, the educational task is complex and in many cases difficult to put into practise,
due to factors detailed later.
Pharmacological mythomania
As we mentioned before, the population places a great expectation of cure on
pharmacological treatment (an undoubted sign that the population is not disconnected
from the enormous amount of information, which is sometimes excessive, about
medicines). Furthermore, concern for health, which is extensive in western countries, has
resulted in the appearance in the majority of homes of the so-called “family medicine
cabinet.” On many occasions, this is the cause of irresponsible self-medication and clear
problems related to adverse effects derived from medicines. It is important to highlight, by
virtue of the different studies carried out in this regard, that in the majority of cases, the
medicines and health products stored in these medicine cabinets do not fulfil the hoped
278
expectations of favouring self-care (4, 5). It is common to see these medicine cabinets
become storage places (almost always in an unadvisable location) for surplus medicines
from different pathological processes, which are frequently out of date and inappropriately
stored.
Therefore, family medicine cabins, far from constituting in the majority of cases a
supply of small solutions for self-care, constitute a source of problems related to the use of
medicines, favouring the appearance of adverse effects and interactions. In short, they
favour iatrogenic effects, and are, in many cases, an ignored source of these.
The welfare society
In our society, medicines also form a part of consumer goods. Accessibility to
medicines forms a part of the concept of social welfare, confusing the social right to health
coverage with the right to the consumption of medicines. The advertising of non-ethical or
over-the-counter drugs through unknown marketing techniques of other consumer
products also contributes to the same process. There is no doubt that modern sales
techniques base a large part of their success on advertising, and the pharmaceutical
industry is not indifferent to this strategy, setting aside a significant financial amount for
this type of spending (3).
The individual in particular and society in general consider access to all consumer
goods that the welfare state provides “just.” Therefore, it seems logical that the right to
consume medicines following the medical act is demanded and required. Furthermore, the
publicity techniques used by the pharmaceutical industry favour this demand.
The advertising of medicines, which is only permitted for over-the-counter
medicines (OTC drugs), influences this circumstance greatly, and by extension the ethical
medicines (those subject to prescription). This establishes a complicated process of selfprescription which we will detail later.
Media influence
The media plays an important role in the world of health. It is difficult to maintain
informative strictness in this matter, occasionally due to the complexity and specialisation
of the subject, and often because the headline takes precedence over the critical
assessment of professionals. The media’s influence in popular culture is huge when it is of
an audiovisual nature, which usually uses more imprecise but more eye-catching messages.
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In short, the role of the media usually presents two facets: occasionally it provides society
with an educational message derived from more accessible language; other times it serves
to create false alarm or false hope.
Advertising can also bring certain disinformation when the story issued has not
been fully verified, which is something that occurs rather frequently. This can even create
unfounded alarm or false hope regarding the curative potential of certain medication
(known as the UTAH phenomenon, and which forms a part of some strategies followed by
pharmaceutical companies in the definitive approval of their product by the health
authorities).
Self-medication and the family medicine cabinet
In general, self-medication (SM) is understood as a situation in which patients
obtain and use medicines without any form of intervention from the doctor (not in the
diagnosis of the illness or in the prescription or supervision of treatment).
The practise of SM has increased considerably in recent years and is currently
estimated at a prevalence of 40-75% in Spain (6, 7). This statistic makes it necessary for
appropriate and sufficient information to be conveyed to patients by different health
professionals in order to ensure SM is performed in a rational, safe and efficient manner.
Doctors frequently do not detect the degree of use of OTC drugs by patients. As
such, when the doctor is completing the clinical history he must consider the use of OTC
drugs and any other kind of medicine – for example, those from herbal medicine that may
even include potentially toxic ingredients – in addition to the use of prescribed drugs.
SM must not be exclusively considered a form of irrational use of medicines: it
should be perceived as a situation with certain positive aspects that, as part of its “self-care
of health,” could be brought back as an important instrument in reducing health costs. It is
understood as a reduction in spending financed by the public entity and therefore
responsibility for it is assumed by the patient.
As the World Health Organisation (WHO) states, responsible SM generates personal
and social benefits:
•
The alleviation or solution of health problems may be done with autonomy and
in a manner that is complementary to the professional practise of doctors.
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•
•
•
The autonomy and responsibility of people for their healthcare is increased.
Waiting times, displacements, time wasting, etc. is avoided.
It contributes to relieving the health system, which is congested by ailments
that could be treated autonomously.
We must not forget that the process of self-care is based on responsible SM
although self-care must comply with previously known and valued processes so the patient
does not run any unnecessary risk due to not receiving appropriate care from a doctor at
the opportune moment.
Responsible SM has suffered a significant development in recent years. Although it
is in its initial stages its scope would be limited to the alleviation of symptoms that are not
serious (mild throat, stomach or ear pain, cough, etc.), it currently covers the prevention
and alleviation of acute health problems and some symptoms of chronic illnesses
(rheumatism, osteoarthritis, etc.). Responsible SM does not aim to push the strategic role
of the doctor to one side: contact with the patient must not disappear. On the other hand,
self-prescription does push the doctor to one side: it is the patient who decides what
medicine to take, probably because he has heard good things spoken about a drug or
because one person around him felt good after taking it.
The consequences of self-prescription may be significant: masking of the illness,
appearance of adverse effects, prolongation or aggravation of the illness, tendency or
resistance to the medicines used, facilitation of infection and promotion of drug
dependency, etc.
Self-prescription often hides the psychological or physical dependency on certain
medicines used to produce changes in the individual’s emotional state. The factors that
coincide and favour the consumption of medicines without a prescription are: the scarce
accessibility of the doctor, the lack of free time in users, and the excessive laxity in the
fulfilment, by pharmacies, of legislation regarding the dispensation of medicines that
require a medical prescription.
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Problems associated with self-medication
The medicines (OTC drugs) available for SM in our country constitute a small part of
the medicines consumed for this purpose. SM with drugs that require a medical
prescription is very common, whether it is through re-use following a previous prescription
or acquired directly in the pharmacy. This Spanish reality results in multiple errors of use
that we must work to modify and channel this towards responsible and positive SM (8).
Among the medicines that frequently present problems of misuse, with regards to
SM, are non-steroidal anti-inflammatory medicines (NSAIMs), antibiotics and psychotropic
drugs (mainly benzodiazepines).
Analgesics
The consumption of analgesics by the Spanish population, and the possible abuse
this may generate, is an undervalued fact. The figures available about the consumption of
this type of medication indicate a massive explosion in society’s use of analgesics in all age
groups and for a wide range of pathological situations (8).
In 1996, the packaging dispensed by the Sistema Nacional de Salud (National
Health System, or SNS) for the group of analgesics including paracetamol, aspirin,
metamizole and lysine clonixinate amounted to 1 package per habitant per year. The
consumption of this therapeutic group in SM implies at least a doubling of the total amount
ingested by our population. Since 1994, the sale of analgesics has risen 23%. If we add the
consumption of associated medicines combined with analgesics, NSAIMs and other OTC
drugs that mix various products with analgesics, we have pain treatment, in its diverse
appearances, as the main clinical activity of a large majority of doctors. One of the risks of
the usual use of simple analgesics is interstitial nephritis. It is estimated that 11% of all
cases of terminal kidney failure, which has an incident rate of around 110 new cases per
million people, is attributed to the consumption of analgesics (8, 9).
The unsupervised treatment of pain has become more complicated through the
widespread use of NSAIMs. Their growing consumption increases the risk of adverse
effects, both in medical prescription and in SM. The incident rate of upper gastrointestinal
bleeding (upper GI) is 650 cases per one million inhabitants per year, of which 40% can be
attributed to aspirin and NSAIMs (10).
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Antibiotics
Diverse studies have addressed the consumption of antibiotics in SM in Spain.
Around 25% of 80 million annual packages of antibiotics are consumed in this way.
However, not only does this figure indicate the misuse of these medicines, it also indicates
that only 6.5% of adult patients and 30.3% of children whose doctors have prescribed them
an antibiotic fulfil the appropriate dosage and duration of the treatment. The majority use
it to feel better. Many of these remaining packages will be re-used. It is estimated that 88%
of the Spanish population receives antibiotics at least once a year (11).
Spain is widely recognised in the scientific community as one of the countries with
the highest bacterial resistance rates, especially in pathogens originating from the
European Community. The exporting of “Spanish clones” of bacteria such as Streptococcus
pneumoniae has identified the Spanish predicament regarding bacterial resistance. The
bacteria originating from the European Community present, in our country, resistance
rates that are among the highest in the European Union. Streptococcus pneumoniae has an
estimated resistance to penicillins of 40%, and 18% to macrolides; Haemophilus influenzae
has an approximate resistance of 40% to aminopenicillins, and a progressively increasing
resistance to fluoroquinolones. Other gram-negative bacteria, such as Escherichia coli and
Pseudomonas aeruginosa have a resistance level to multiple antimicrobials (including
cephalosporins) with worrying growth (8).
In a quantitative study on SM with antibiotics in the Spanish population performed
in pharmacies through a personal interview of clients who had acquired an OTC drug in
different autonomous communities over the course of a year, some revealing results were
obtained in relation to the problem analysed (12).
32.1% of people who had acquired an antibiotic in the pharmacy had performed SM
with antibiotics, while the figure was 28.8% regarding people who had acquired OTC drugs.
20% of cases occurred via the direct request of the user while 12.1% were due to the
recommendation of the pharmacist/assistant. Two in three people obtained a broadspectrum semisynthetic penicillin and 23% obtained a macrolide (13).
SM is, along with therapeutic non-fulfilment and the storage of antibiotics in the
home, one of the most serious problems of antibiotics today, given that it is frequently
accompanied by misuse. It is necessary to develop health education programmes in which
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doctors and pharmacists actively participate to raise awareness in the population about the
negative effects of SM and to guide patients in the rational use of antibiotics.
On the other hand, the administration must convey to the pharmacist the
inappropriate nature of dispensing antibiotics without the corresponding prescription.
Using antibiotics in a “rational” and appropriate manner constitutes an obligation
and fundamental challenge to maintaining a correct balance between good clinical practise
and the need to reduce the impact of bacterial resistances.
Psychotropic drugs
Psychotropic drugs are a group of medicines that are widely used nowadays, given
that their consumption has experienced significant growth in the last 25 years, with
benzodiazepines being the most widespread pharmacological group. As such, psychotropic
drugs have been cited as one of the most inappropriately used groups in patient SM.
Psychotropic drugs also constitute one of the most consumed pharmacological groups by
elderly people, the majority of whom are polymedicated. Therefore, it is important to
streamline and periodically review the consumption of drugs received by elderly people,
especially in those who live shut away in their homes. This part of the population presents
a multifactorial risk that is increased by the consumption of psychotropic medicines, which
may encourage the low response capacity this type of patients present when faced with an
accident, and therefore, a greater risk of falling at home.
The incapacity of a family member is a potentially stressing factor within the family.
This state of anxiety may increase the consumption of psychotropic drugs by incapacitated
patients and their carers. The consumption of psychotropic medicines in these chronic
home patients is high and occasionally the result of SM. Its relation with a greater
prevalence of falls in these patients highlights the need to have an impact on prevention by
educating carers, preventing home accidents, increasing social assistance, improving
orthopaedic aid, correcting visual/audio deficits and, of course, reducing the consumption
of psychotropic drugs. The high consumption of psychotropic medication detected in these
patients also underlines the important of health education in the daily prescription (14, 15).
Other medicines
Any medicine, regardless of its benefit/risk profile, may have the potential to be
misused. OTC drugs have characteristics of lesser risk that were defined in 1986 by the
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Regional Office for Europe of the WHO (16): they must be efficient against the symptoms
that provoke their use, which, in general, must be of a self-limited nature, meaning they do
not display progressive or aggravated evolution; they must be reliable in giving a consistent
and sufficiently swift response so those who consume them note their beneficial effects;
and, of course, they must be safe, given that they must be used in situations of good
prognosis and for an ailment or illness whose identification is not difficult for the amateur.
They are illnesses that, due to their frequency and characteristics, can be easily diagnosed.
Finally, their use must be easy and comfortable so the user does not require
complex and uncommon precautions. They must have a wide therapeutic margin – errors
in dosage must not have serious repercussions. Furthermore, it is recommended that the
information pamphlet details the specific situations when the individual should consult a
doctor.
Under these conditions, OTC drugs can enable correct SM. In recent years, a large
number of medicines have modified their medical prescription requirement for OTC drug
sale, especially in English-speaking and Scandinavian countries: ranitidine, loratadine,
topical antifungals, beta-2 mimetics, etc. Their ease of use and freely available nature can
result in errors in their application and errors in the overall tackling of the illness for which
they are taken. Without educational activity regarding the use of medicines, the change in
legislation regarding the mechanism of acquisition from the pharmacist does not guarantee
better use (8).
In summary, we can argue the potential risks of OTC drugs could be group as
follows:
•
•
•
•
•
•
Excessive dose of drugs
Adverse reaction to these medicines
Interaction between prescribed drugs and OTC drugs
Masking or delay in the diagnosis of clinically serious situations
Self-medication of analgesics and other hypnotic OTC drugs has been associated
with an increase in the death rate of the elderly
OTC herbal medicines
SM is a reality that must be accepted. Health information and education can help to
make it a responsible and positive practise, and to eradicate undesirable and dangerous
SM.
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Doctors are educators and technical experts in the task of helping patients and their
families to care for and re-establish their own health. This manner of understanding the
medical profession as a support method for self-care is very different to that which has
dominated up to now: the role of the tribe’s witch doctor to whom people who go with
fear and veneration. In this context, self-care and SM represent a significant pillar in this
way of understanding the relationships between doctors and patients. It is a relationship of
advice and education, in addition to curing the illnesses presented (8).
Treatment adherence
The medical act is established through mutual trust, considering that without it the
level of doubt in the doctor and the patient grows until the relationship between them
becomes impossible. Both premises lead to the conclusion that there is an external
element that determines that a treatment is started but is not completed due to mistrust.
The lack of treatment adherence observed mainly in patients affected by chronic
processes (30-60% in people with high blood pressure) or those subject to polytherapy is a
pressing issue in terms of the efficacy of the prescribed treatment and the indirect costs it
results in.
Treatment adherence could be expressed as the degree of agreement between the
medical/health directions, not limited to the treatment directions, such that it includes
attending scheduled appointments, participating in health programmes, searching for care
and modifying one’s lifestyle. Adherence is a dynamic concept that can affect every stage
of the clinical process.
Furthermore, the therapeutic alliance or agreement between the doctor and the
patient, assessed from the ethical principle of autonomy, will strengthen trust and will be a
determining factor in treatment adherence.
The issue derived from the situation of adherence/non-adherence is the most
obvious border that separates and distances the efficacy of medicines (use of drugs in ideal
conditions, like in clinical trials) and their effectiveness (use of medicines in normal and
therefore real conditions). In order to obtain maximum benefit from a treatment, which is
the main objective of medicine, it is essential that the patient adheres to the treatment,
which, as we have already mentioned, is usually at a lower rate in chronic illnesses, as
these usually have a versatile and prolonged dosage regimen. Non-compliance is not only
the failure of the patient, it also involves, to some extent, the failure of the doctor
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(diagnosis and prescription), the nurse (nurse consultations) and the pharmacist
(dispensation).
Statistics highlight that, currently, there are many patients who do not follow their
pharmacological treatment to the letter. This is more obvious in relation to patients
affected by a chronic illness or those who have to take diverse medicines every day. Some
specific data serves as examples of this: between 29% and 66% of people who take
medicines to reduce high blood pressure do not adhere to their treatment; with regards to
medicines for cholesterol or triglycerides, this failure to adhere to treatment is between
40% and 60%; with antiasthmatics, it is between 25% and 56% of people (17, 18).
Concepts related to treatment adherence
Adherence: extent to which the patient responds to the indications of the doctor,
accepts them and “makes them his own.” This does not only refer to medicine: it also
includes non-pharmacological measures (measures related to hygiene, diet, control, etc.),
which form a part of the overall treatment process that hopes to cure, improve, remove
symptoms, etc.
Observance: the conduct of the patient reasonably coincides with the collection of
measures and the behaviours indicated by the doctor.
Compliance: when the treatment instructions are followed and fulfilled correctly.
Careful and detailed information with simple and accessible language is the first step to
guaranteeing compliance and adherence.
Non-compliance: when the instructions are not followed or fulfilled due to abuse
(hyper-compliance) or due to omission (hypo-compliance).
What factors influence treatment non-compliance?
Patient characteristics: probably age (related to cognitive changes and frequent
polytherapy), cultural level (greater number of offenders in the stratum of the population
with a lower cultural level), the family environment and the psychological state of mind of
the person as factors related to the patients who are mainly involved in non-compliance.
Illness type: non-compliance is highest in patients in asymptomatic stages and in
patients with chronic illnesses as they need prolonged treatments (diabetics, people with
high blood pressure, epileptics). Non-compliance usually has a lower rate in patients with
acute or serious illnesses.
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Health staff member-patient relationship: the degree of adherence depends largely
on the quality of communication and satisfaction of the patient, mainly with the doctor.
The community pharmacy may provide an important support mechanism in improving
treatment adherence. Furthermore, the grouping of problems related to medicines, if
communicated to the doctor responsible for treatment, may help when offering the
patient changes to the treatment such that his adherence is improved. The other option is
to refrain from interfering in the prescription designed by the doctor and issue the patient
with this despite suspicions over factors that may result in non-compliance by the patient
(intolerance to the oral administration of medicine, mild adverse reactions,
incomprehension of the therapeutic objective), which on many occasions requires the
reconsideration of the treatment by the doctor through dialogue with the patient, for the
purpose of designing the appropriate guideline that is accepted by the patient, and which
definitely involves him in his cure process. The monitoring of treatment must not be an
aspiration of “pharmaceutical care,” as it will result in greater confusion in the patient and
a distance forming in the doctor-patient relationship. Treatment is an act derived from the
profound knowledge of the health and illness of the human being, therefore its design and
development may only fall upon the professional trained in this matter, with this person
being none other than the doctor.
Treatment type: duration, confidence in the efficacy of the medicine, dosage
regimen (method of administration, pharmaceutical form, interval of administration, mono
or polypharmacy, complexity of the prescription, etc.).
Consequences of treatment non-compliance
There are multiple consequences and variable repercussions of treatment noncompliance: death due to cardiovascular illnesses and infections, hospitalisations,
increased medical visits, prescription of additional diagnostic tests, alternative, additional
or unnecessary treatments, home storing of medicines, increased health spending, etc.
Some of the consequences of non-compliance are listed below (19).
Consequences of the underuse of medicines
o Lack of response to treatment
o Delays in cure
o Relapses or recurrences
o Creation of resistances to antibiotics
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o Appearance of new pathologies
o Mistrust
Interference in the doctor-patient relationship. Erroneous assessment of real
effectiveness
o Unnecessary increase in treatment dosage
o Elimination of safe and efficient drugs
o Introduction of other, more powerful medicines with greater toxicity
o Storing of medicines
o Accidental intoxications from unconsumed drugs in family medicine cabinets
o Irresponsible self-medication
Financial repercussions (medicines that are acquired but are not consumed)
o Occupational absenteeism
o Lack of productivity
o Increase in health spending
Consequences due to overuse of medication
Greater risk of the following:
o Undesired side effects
o Toxicity
o Dependency and tolerance
Strategies for improving treatment adherence
Different strategies aimed at alleviating this problem have been devised. Some of
these are described here, along with the impact of their employment. Among the
strategies detailed, those that involve both the patient and the doctor stand out.
Doctor-patient communication
It is important to foster a climate of trust and empathy with the patient by
dedicating the necessary time to informing him about the illness, the importance of
treatment, the possibility of adverse, transitory effects appearing, such as tolerance, etc.
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Therefore, the prescriber must take an interest in fulfilling each of the follow-up visits and
assess the patient’s point of view by promoting his initiative, participation and
responsibility in the decision making process (What motivates him to follow instructions?
Why is it important to him?). In order to achieve this, it is necessary to increase the average
consultation time per patient.
Patient advice
Describing the treatment and its effects in a manner that is understandable to the
patient is the essence of education and, as a result, a more collaborative patient who
actively participates in his own treatment programme is achieved. Educational leaflets and
material cannot replace the need for direct communication. The use of illustrated cards or
pamphlets that help the patient to remember the dosage regimen, labels stuck to
packaging, etc. can also be useful. In this sense, the adjustment of information pamphlets
aimed at the patient can be a good alternative.
Simplification of the treatment regimen
This is of particular importance in patients with chronic, asymptomatic diseases
such as high blood pressure or hypercholesterolemia: for example, reduce the frequency of
the dosage, choose delayed release dosage forms when appropriate, eliminate
unnecessary treatments, and adapt the dosage regimen to the daily routine of the patient.
Of course, reaching a “treatment agreement” in which the patient feels he is involved and
has been “heard” is important.
Monitoring the response
Ask the patient to ensure he has correctly understood the guidelines, dosage and
duration of treatment, and to assess adherence at subsequent visits (the Morisky-Green
test or the Haynes-Sackett methodology can be used); monitor care during follow-up visits
and increase the frequency of these if necessary, use administration “calendars” or
“diaries,” involve carers in the management of medication, etc. In this regard, coordination
with other health professionals is becoming more and more important.
PDS programme: personalised dosage system
The aim of this programme is to collaborate on improving treatment adherence in
patients, which stands at around 50% for certain diseases. The pharmacies that participate
in the Personalised Dosage System (PDS) offer users the option of accessing the medicine
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they need daily, which is available in specially designed packaging to avoid confusion and to
facilitate as far as possible treatment adherence.
The advantages of the PDS are obvious, especially for certain types of users, for
example, those who are subjected on a daily basis to a treatment that includes three or
more drugs, or those who take decreasing, alternate or irregular dosages. They are also
evident in elderly patients who have difficulties adhering to the treatment due to cognitive
and handling problems.
Need to measure the quality of prescription?
Prescribing indicators
An indicator is a measuring instrument that enables us to quantify something.
Quantitative indicators that enable us to perform a quantitative assessment of the
prescription of a certain doctor, team, area or province exist (number of prescriptions,
packaging, cost per prescription, cost per user, etc.).
Qualitative indicators also exist. These enable us to quantify an assessment, which is
mainly qualitative, of the prescription; these are Quality Prescribing Indicators and they
aim to:
•
•
•
Detect the use of unsuitable medicines.
Detect the insufficient use of medicines with proven efficacy (for example,
morphine-based medicines in terminally ill oncology patients experiencing
pain).
Detect the excessive use of a certain drug in comparison with alternatives that
have a more favourable benefit/risk/cost ratio.
The characteristics an indicator should gather are as follows:
•
•
•
•
•
•
Sensitivity and reliability.
Must address relevant issues.
Must be justified from a scientific perspective.
Must be agreed.
In order to be valid, the consumption of the product, to which it refers, must be
high.
Must be easy to obtain.
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•
Definition must be understandable.
Among the most used qualitative indicators are those based on the intrinsic value of
all prescribed drugs and those that establish a hierarchy of the use of medicines that are
employed in the same instructions (first line, second line and exceptional use), establishing
levels of use depending on benefit/risk/cost criteria.
However, all of these indicators, whose information source is the mechanised and
computerised data from the medical prescription, are difficult to interpret when diagnostic
or additional information about the instruction, the treatment outline followed or the
characteristics of the patient treated is not available; all of these aspects are essential
details in evaluating the quality of the use of medicines with a high intrinsic value.
Even when 100% of the medicines prescribed have a high intrinsic value, it cannot
be confirmed that this is due to quality of prescription, given that they may be used in
inappropriate situations where no indication for their use exists. On the other hand, in
recent years the drugs that have been introduced to the market have a high therapeutic
index (although the vast majority are barely innovative, as they provide few advantages to
those that already exist) and, consequently, the overall high intrinsic value indicator for the
drugs prescribed will continued to be of ever more limited value.
There is no doubt that quality indicators are a useful tool in measuring the quality of
prescription as a mechanism for periodic monitoring, describing occasional situations or as
a source of information for consultants. However, we must continue to promote rigorous
methodology studies on indication-prescription and the treatment outline followed and
appropriately adapted, with reviews to clinical histories, in order to define some optimal
standards for these indicators that are based on scientific data and epidemiological
profiles, avoiding criteria that are strictly financial in nature.
Factors depending on the health administration
As we have already mentioned, the doctor must accept his share of responsibility
for the efficient management of the resources he uses, although it is true that it is
politicians and managers who must arbitrate the political and administrative measures
needed to adjust pharmaceutical spending to what the State is willing to accept.
Although it is true that using medicines of doubtful or zero efficacy (or using
unnecessarily new drugs that do not provide any advantages over those that are already
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available, or if they have an unfavourable benefit/risk/cost ratio) generally involves a poor
quality of prescription, it is also true that the health administration is the organisation
responsible for said products finding their way onto the market and enjoying public
financing. On the other hand, significant technological development has contributed to the
appearance of new medicines, some of which are hugely important as they fill in the gaps
in treatment, but they have one significant problem: their price. This has forced the health
administration to establish criteria for the prescription of some of these drugs, including
the limitation of the prescription by the specialist doctor or the application of
endorsements, both at a hospital level and a primary care level.
When we attend to an illness we undoubtedly seek the best therapeutic proposal.
Occasionally the use of recently introduced drugs sparks the interest of the doctor who is
keen to treat his patient with the best pharmacological options available. For example, it is
obvious that, when treating a patient with a history of peptic ulcers and who needs to
receive an antiplatelet treatment, the doctor proposes two situations: administering
aspirin and an antisecretory drug, or administering ticlopidine or clopidogrel. As such, if we
compare the cost of administering clopidogrel or aspirin, the most reasonable option from
a financial point of view is to prescribe aspirin, which is why it has been decided by the
administration to grant clopidogrel with the need for an endorsement before it may be
prescribed. Even still, we have not yet solved the issue of taking preventive action against
possible upper gastrointestinal bleeding.
Choice of medicines
The number of commercialised pharmaceutical specialities in western European
countries presents wide variations depending on the different structure of the market, the
regulations of the patents system and the policy of existing records. Therefore, Spain, for
example, has a pharmaceutical appearance figure that is three times higher than those in
Nordic countries, a fact which, far from improving the quality of prescription, contributes
to hindering the task of the doctor when deciding on the appropriate drug, inducing
greater confusion and increasing the demand for information, which increases the pressure
of the pharmaceutical industry on the prescribing doctor.
Registration of new drugs
When authorising the registration of a certain medicine, safety, efficacy and quality
of manufacture must be guaranteed. This evaluation is the responsibility of the Agencia
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Española del Medicamento y Productos Sanitarios (Spanish Agency of Medicines and
Health Products, hereinafter AEMPS).
For too long authorisation has been matched by financing, meaning it has been
necessary to resort to drastic measures, such as selective financing, to address the
problem.
Currently, and depending on the new reference prices, it is the director of the
AEMPS who determines treatment innovations (Order SCO 2958/2003).
In recent years, it has been confirmed through diverse studies that some of the
medicines registered and even financed by Social Security do not possess proven clinical
efficacy and are considered pharmacologically unacceptable due to having a clearly
unfavourable benefit/risk ratio. This proportion of useless drugs varies a lot between
countries, depending on the different registration systems.
Financing of pharmaceutical compensation
Overall, 91% of pharmaceutical spending is contributed by the State while only 9%
is contributed by users, a figure that has a tendency to decrease year after year (in 1984 it
stood at 15.75%).
In our country, like in others (such as the Netherlands and Germany), only a part of
the price of the medicine is financed by applying so-called reference prices, which consists
of setting a maximum price per medicine, with the patient being responsible for the rest if
the prescribed product has a cost superior to that of the reference price.
The pharmaceutical industry
The pharmaceutical industry must provide doctors with scientific and technical
information about its products so they can judge the convenience of prescribing them.
However, this information continues to move towards promotion and therefore to
encouraging the consumption of medicines. Occasionally, excessive pressure is placed on
the doctor who addresses different aspects (3):
•
Insistent repetitions of the advertising message; it makes people think of a
product that has been known for some time
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•
•
•
The continuous appearance of new medicines that exceed previous drugs in
partial aspects, but which are not always sufficiently verified, and which do not
provide significant therapeutic advancements but which encourage their
prescription.
The volume of informative material that is offered hinders a carefully
considered study of the advantages a medicine provides and the decision of
prescription remains at the mercy of the impression this causes. The material
received through a medical visit to a primary care doctor exceeds a total cost of
€3000 per year.
The creation of vicious circles of questionable ethical justification, among
promotional aspects of the pharmaceutical industry and the health professional
(mainly the doctor and the pharmacist).
In light of this situation, which impacts in an obvious, widespread manner on
prescription habits, we believe the original idea – that the pharmaceutical industry informs
about the scientific and technical characteristics of the product, through considering the
option of meetings together with clinical pharmacologists where debates are hosted, from
a scientific perspective, regarding the contributions to and the scope of study of new
medicines – is advisable. This would achieve greater balance between simple promotion
and scientific contribution to the knowledge and training of doctors with regards to the use
of medicines.
As such, it is recommended that the figure of the pharmacologist is promoted as a
professional who is capable of integrating and assessing the information offered by the
pharmaceutical industry and conveying it in an objective and critical manner to teams at
periodic meetings.
Problems related to the substitution of medicines
As we have already mentioned, the information the doctor receives about
medicines mainly comes from the pharmaceutical industry. Furthermore, the medicines
market in our country considers a large number of specialities that make their evaluation
by the doctor difficult. It is often difficult to differentiate original medicines from “copy”
licences.
Furthermore, the classification of medicines as pharmaceutical specialities (known
as EQ, using their Spanish acronym) by virtue of their possible interchangeability further
impedes the perspective on medicines. As we will go on to discuss, prescription according
to active ingredient, for which it may be useful to standardise the panorama of medicine,
295
does not provide advantages from a financial point of view and, furthermore, it presents
important issues in relation to efficacy and safety.
For a long time, a premise that has been erroneous has been permitted: two active
ingredients with the same chemical composition are equal from a therapeutic point of
view. In short, they present the same efficacy and safety, therefore, to apply a more recent
concept, they are bioequivalents. How did this error come about? We have attempted to
explain it in a staggered manner.
What are chemically or pharmaceutically equivalent specialities?
They are those that contain the same qualitative and quantitative composition in
medicinal substances and have the same pharmaceutical form.
What are pharmaceutically alternate specialities?
They are formulations that contain the same qualitative composition but which
differ in quantity, dosage and/or pharmaceutical form. As such, we cannot use them
interchangeably on a patient if we do not perform the appropriate dosage adjustment and
change the method of administration.
What are therapeutically equivalent medicines?
Two formulations of medicines are considered therapeutic equivalents when they
contain the same qualitative composition and demonstrate the same activity, efficacy and
safety from the perspective of clinical use.
What are bioequivalent specialities?
Those that have been classified as such by the director of the AEMPS. To be
classified as such, the possibility of interchanging the specialities by virtue of the fact they
present the same qualitative and quantitative composition in medicinal substances,
pharmaceutical form, dosage, administration method and therapeutic equivalence must be
considered.
Therefore, medicines on which bioequivalence tests (generic pharmaceutical
specialities) have been performed will be considered bioequivalent specialities if they meet
the stipulated parameters, as will others with the same qualitative and quantitative
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composition in medicinal substances, pharmaceutical form, dosage, administration method
and therapeutic equivalence.
All of these, when they are grouped within a homogenous group, will have the
letters “EQ” printed on their packaging.
The concept of “interchange” between pharmaceutical specialities is introduced.
This is the possibility that the pharmacist may change the medicine prescribed under the
regulations developed in the Royal Decree on Reference Prices, which we will come to
later.
What is a homogenous group?
Homogenous groups are formed by all the pharmaceutical formulations that have
an identical quantitative and qualitative composition, dosage, pharmaceutical form and
administration method, and which have been classified as bioequivalents (with the letters
“EQ” on their packaging). Therefore, they can form a part of a homogenous group of
pharmaceutical formulations authorised under a trade name, Denominación Oficial
Española (Official Spanish Denomination, or DOE) or Generic Pharmaceutical Specialities
(EFG, using the Spanish acronym), as long as they have the letters “EQ” on their packaging.
Each homogenous group will have its own reference price that will be the same for all
those products that constitute that particular homogenous group.
The modifications to Royal Decree 1035/1999, in accordance with Order SCO
2958/2003, state, in the first article on the determination of new groups and the approval
of reference prices, the new groups created as well as the consideration of innovative
pharmaceutical forms, the constitution as groups independent to the products indicated
for paediatrics treatments, and the pharmaceutical specialities for those that have a
significantly different dosage for a specific indication.
The reference prices applicable to each of the groups will be obtained, in
accordance with the aforementioned legal text, through calculating the arithmetic mean of
the three lowest costs per treatment per day, which in turn are calculated according to the
daily dosage defined from the formulations of pharmaceutical specialities gathered in the
groups by each method of administration. In any case, the result of this formula will be
subject to the fulfilment of one condition: the provisioning of pharmacies is guaranteed.
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Concept of bioavailability
Bioavailability defines the amount of drug that actively reaches systemic circulation
and the speed at which it does so. It depends on the physiochemical characteristics of the
drug, the excipients, the manufacturing process and the conservation of the
pharmaceutical form in addition to the individual characteristics of the patient (intestinal
motility, gastric pH, metaboliser phenotype, etc.) Two pharmaceutical specialities will
present an equivalent bioavailability and therefore they will be bioequivalents if certain
pharmacokinetic parameters related to the quantity and speed the drug reaches systemic
circulation do not differ from an established percentage in relation to the original reference
drug. Two drugs are considered bioequivalents when a percentage difference superior or
inferior to 20% in relation to the aforementioned parameters does not exist.
It is important to distinguish that the concept of bioequivalence referred to
previously differs from the concept defined from the administrative facet of
interchangeability. The bioequivalence to which we refer when the aforementioned kinetic
parameters do not stray from this +/- 20%, means the equal biological effects of the two
drugs are demonstrated. Although, in many cases, even this small pharmacokinetic
variability can imply a lack of efficacy or safety problems from a clinical point of view.
Terms that are not exactly synonyms are used with some frequency and they may
result in ultimately significant confusion. For example, the term of “pharmaceutical
equivalent” is often erroneously used as a synonym for “bioequivalent.” Two medicines are
“pharmaceutical equivalents” when they contain the same qualitative and quantitative
composition in medicinal substances and the same pharmaceutical form. Pharmaceutical
equivalence does not necessarily imply bioequivalence, as there may be differences
attributable to the excipients or to the manufacturing process that give rise to significant
differences regarding the kinetic behaviour of both drugs, and therefore of their
bioavailability.
This also occurs with pharmaceutical alternate specialities, which contain the same
qualitative composition but which differ in quantity, dosage and/or pharmaceutical form.
In these cases, the interchangeability of the medicines to obtain identical therapeutic
results would require the appropriate dosage adjustment or modification to the
administration method.
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Limitations of bioequivalence studies
a) Practical limitations due to the vague nature of international recommendations on
the design and development of the studies and pharmacokinetic and statistical
analysis.
b) Uncertainty over the interpretation of the results.
c) Conceptual limitation regarding the interchangeability of the prepared samples and
regarding the extrapolation of data for the general population.
d) Limitations of the classic factorial design according to the characteristics of the
drug.
Legal aspects related to the medicine: reference prices
In 1999 Royal Decree 1035/1999, of 18 June, was enacted to regulate the reference
price system in the financing of medicines with Social Security funds or State funds set
aside for health.
In this Royal Decree, the following concepts are outlined:
1. The reference price system is regulated, which, in turn, is how the financing –
through Social Security or State funds set aside for health – of pharmaceutical
speciality formulations that are included in the homogenous groups that are
determined by the Health and Consumption Minister and which are prescribed and
dispensed through an official medical prescription, to which the user has the right,
will be governed.
2. The need for the formulations affected by reference prices to be bioequivalents and
form a part of homogenous groups is established. The classification of
bioequivalence will be given by the director of the AEMPS, and he must consider
the possibility of interchangeability of the specialities in terms of the same
qualitative and quantitative composition in medicinal substances, pharmaceutical
form, dosage, administration method and therapeutic equivalence.
3. A reference price for each homogenous group (there are 114 homogenous groups)
is established, with this being the maximum amount that will be financed using
Social Security funds or State funds set aside for health and the services of
pharmaceutical specialities included in this. Furthermore, the criteria for the
reference price calculation and the frequency of updates are established.
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4. With regards to the labelling of pharmaceutical specialities formulations that are
classified as bioequivalents and are included in a homogenous group, the letters
“EQ” must be stated on the label. This measure also applies to the generic
pharmaceutical specialities affected.
5. The Royal Decree regulates the substitutions the pharmacist will be obliged to fulfil.
It establishes that when the price of the formulation of the prescribed
pharmaceutical speciality bioequivalent exceeds the amount established as a
reference price, and the beneficiary does not opt to pay the difference between the
price of the pharmaceutical speciality prescribed and the set reference, the
pharmacist must substitute it for a generic pharmaceutical speciality of the same
homogenous group whose price does not exceed the reference price. As such, the
corresponding exceptions are established when the doctor accompanies the
prescription with a detailed report that irrefutably justifies the unsuitability of
substitution due to allergy, intolerance or any other incompatibility of the
beneficiary in place of the document that may detail the substitution of the
prescribed speciality.
6. The Royal Decree establishes the financing of the pharmaceutical specialities
formulations affected by reference prices and the commercialisation conditions of
generic pharmaceutical specialities. Finally, it refers to the Order of the Health and
Consumption Minister for the determination of the homogenous groups.
As we mentioned, on 25 October 2003, the Order SCO 2958/2003 was published on
the Boletín Oficial Estatal (Official State Gazette, or BOE), determining the new groups of
pharmaceutical specialities formulations and the corresponding reference prices were
approved. The modifications introduced to Royal Decree 1035/1999 mainly affect the
conditions required for the establishment of groups and the exclusion, for the purposes of
integration in these groups, of innovative pharmaceutical forms until the corresponding
generic pharmaceutical speciality is authorised.
The number of pharmaceutical speciality groups is 82. The responsibility for
classifying them as innovative pharmaceutical forms corresponds to the director of the
AEMPS, and he must consider the clinical evidence available that is aimed at directly or
indirectly increasing therapeutic efficacy.
Independent groups are established for the formulations indicated in paediatric
treatments, in addition to those pharmaceutical specialities for which a significantly
different dosage exists for a certain indication.
300
The new calculation method for the reference price corresponding to each group is
also formed. It is based on the arithmetic mean of the three formulations that present a
lower cost per treatment per day.
Substitution by the pharmacist
In this regard, article 5 and sections 3 and 4 of article 6 are repealed. In short, those
that refer to substitution by the pharmacist. In summary, we can state that the doctor loses
the chance to block the substitution by making use of a detailed report in which the
reasons for said decision are justified.
Below are the four sections of article 3 of the new Order, which address
substitution by the pharmacist of the pharmaceutical speciality prescribed and
dispensation in the event of prescription according to active ingredient.
1. In compliance with what is set forth in the seventh paragraph of article 94.6 of the
Medicines Law 25/1990 of 20 December, the pharmacist will fulfil the prescription
made by the doctor in accordance with the following:
•
•
When the doctor prescribes a pharmaceutical speciality whose price is
equal or inferior to the reference price, the pharmaceutical speciality
prescribed will be dispensed.
When the doctor prescribes a pharmaceutical speciality whose price is
superior to the reference price, and if generic pharmaceutical specialities
that may be used as a substitute exist, the pharmaceutical speciality
prescribed should be substituted by the generic pharmaceutical speciality
of a lower price, in accordance with information set out in appendix III of
the Order.
• When the doctor prescribes a pharmaceutical speciality whose price is
superior to the reference price, and if a generic pharmaceutical speciality
that may be used as a substitute does not exist, the pharmaceutical
speciality prescribed will be dispensed at the reference price.
2. On the other hand, in compliance with the guidelines established by the eighth
paragraph of article 94.6 of the Medicines Law 25/1990 of 20 December, the
pharmacist will fulfil the prescription made by the doctor in accordance with the
following: when the doctor prescribes according to active ingredient, which is
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subject to the reference price, the generic pharmaceutical speciality of the lowest
price must be dispensed, in accordance with the information outlined in appendix
III of the Order. If a generic pharmaceutical speciality of a lower price does not exist,
the pharmacist will dispense the brand pharmaceutical speciality corresponding to
the prescription made at the reference price.
3. In all of the scenarios referred to in sections 1 and 2 of this article, the generic
pharmaceutical speciality susceptible to dispensation must have an identical
qualitative and quantitative composition in medicinal substances, pharmaceutical
form, administration method, dosage and formulation of the pharmaceutical
speciality prescribed or the speciality corresponding to the prescription according to
active ingredient.
4. For the purposes established in this article, it is understood that a generic
pharmaceutical speciality of substitution does not exist when said speciality is not
available on the market or when it is not included within the pharmaceutical
services of the Social Security.
We believe it is necessary to introduce the following modifications in relation to
substitution. When the patient and the doctor agree to it and the doctor signals this in
the appropriate place on the prescription, the pharmacist will dispense the
pharmaceutical speciality prescribed by the doctor to the beneficiary.
The formulations of pharmaceutical specialities included in the different groups
whose prices exceed the corresponding reference will only be the subject of financing
using Social Security funds or State funds earmarked for health up to their reference
prince and in accordance with the guidelines of the regimen that applies to them. When
the profile of the doctor does not exist on the prescription, the pharmacist will inform the
beneficiary of the possibility of paying the difference between the pharmaceutical
speciality prescribed and the reference price, or even substituting it for a generic
pharmaceutical speciality that does not exceed this reference price, in addition to
calculating, where applicable, the economic contribution that would apply over the
reference price.
As has been mentioned throughout this document, the national pharmaceutical
market is complex. It consists of original medicines, license, copies, generic
pharmaceutical specialities and the incorporation of the letters “EQ” on the packaging of
medicines included within homogenous groups as a guarantee of interchangeability.
However, only in generic pharmaceutical specialities have clinical trials of bioequivalence
302
been carried out (which ensure, from a scientific perspective, an absolute guarantee of
equal efficacy and safety against the original reference drug).
The possibility of substituting the medicine prescribed by the doctor in the
pharmacy impedes the wishes of the doctor regarding the use of generic pharmaceutical
specialities. In a survey carried out recently by Sigma Dos, one of the reasons highlighted
by the doctor in justifying the low use of generic medicines is the indiscriminate
substitution of generic pharmaceutical specialities that incorporate the laboratory name
for other therapeutic equivalents (whether they are generic drugs or not) that are usually
dispensed in the pharmacy, without the doctor being informed of said substitution at any
point.
Therapeutic novelty does not always improve what already exists. Even experience
demonstrates a large quantity of new, recently introduced molecules in the therapeutic
arsenal that must be withdrawn due to the presentation of significant adverse effects.
However, the continuous pressure to which the primary care doctor is subjected, including
the problems derived from the treatment of chronic illnesses and the deterioration of the
doctor-patient relationship resulting in the substitution of medicines, leads to the doctor
channelling the prescription towards recently introduced medicines for which generic
drugs have not yet been developed and which are not yet regulated by reference prices.
This attitude may never be justified but it is a reality we must assess as it is determined by
the measures that, up to now, have been put in place by the health administration.
We understand the introduction of a box on the prescription that guarantees the
prescription of the doctor would result in an increase in the generic medicines market.
In the European Union countries where reference prices function, two different
types of substitution are carried out. In Germany, the pioneer of the system, it is during the
medical consultation when the patient and the doctor decide finally if it will be a generic
pharmaceutical speciality or a branded product that will figure on the prescription and will
be dispensed in the pharmacy. In all other European countries, substitution occurs in the
pharmacy, but prescriptions include a special box where the doctor can object to this. In
Spain, a “third way” has been chosen, in which the doctor remains absolutely outside of
the system and is not permitted an opinion in the substitution process. We believe that
Spanish doctors are also European doctors.
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Prescription according to Denominación Oficial Española (DOE) or International
Nonproprietary Name (INN)
We do not assess the importance of prescription according to active ingredient in
relation to a philosophy aimed at increasing the use of generic pharmaceutical specialities,
instead, we assess it in relation to the problems that this measure, by virtue of mainly
economic factors, may give rise to in therapeutic pharmacology.
We previously stated that bioequivalence studies are the unique tests, from a
scientific perspective, that can assess the interchangeability of two medicines.
Furthermore, we determined that even these studies present methodological problems
that may invalidate the option of substitution. We are referring to, among others, the
drugs that present non-linear kinetic behaviour, drugs with a narrow therapeutic index,
pharmaceutical specialities that are presented for delayed administration, or even drugs
that may see their absorption altered in the presence of foodstuffs (not all bioequivalence
studies have considered this circumstance). In summary and in a simplistic view, the
excipient varies between different medicines and this, in many cases, is the key concept in
the time needed for the liberation and dissolution of the active ingredient and, therefore,
in its bioavailability. It must not be forgotten that the excipient may potentially be the
cause of adverse effects, whether directly or by interfering in the mechanisms of
elimination for the active ingredient.
Obviously, “copy” medicines would not even enter into the debate of pertinence or
of not completing the prescription according to active ingredient. The main reason resides
in the fact that these medicines, although classified as interchangeable, have not
undergone bioequivalence studies. Therefore, their bioavailability in relation to the
reference medicine is not documented and although theoretically they may present a
similar profile of efficacy and safety, this has not been proven with the appropriate
methodological criteria.
Therefore, it is not absurd to state that non-bioequivalent pharmaceutical
specialities, drugs with a narrow therapeutic index, drugs that present non-linear kinetic
behaviour and medicines with active agents that have not been assessed by bioequivalence
studies (“copies”), along with those formulated to have a delayed effect must not form a
part of the lists for prescription according to active ingredient.
In short, rather than a common prescription according to active ingredient, which
almost exclusively aims for a reduction in pharmaceutical spending (which is still to be
demonstrated, as we will mentioned later), we must make a greater effort to encourage
the use of generic pharmaceutical specialities. To do this, we must promote the removal of
304
“copy” medicines from homogenous groups such that the letters “EQ” really declare a
bioequivalence in terms of bioavailability. Finally, it must be emphasized that the
prescriber’s task must be facilitated. The aforementioned problems with interchangeability
for some drugs, as well as the presence of different excipients in the different specialities
that contain a unique active agreement make it desirable for the doctor to be able to freely
choose the medicine he considers appropriate for his patient, in a manner where no
external factors that may endanger a certain pharmacological treatment proposal exist.
Prescription according to active ingredient, which has been adopted by some health
administrations, limits the ability of the doctor regarding the prescription while opening
the door to the decision of the pharmacist who is often disconnected from the clinical
situation of the patient and subject to interferences that are external to the treatment
proposal suggested by the doctor.
From a pharmacological perspective, there is a large group of drugs and occasionally
therapeutic groups that show enormous difficulties in generalising substitution between
medicines that contain the same active ingredients. As we have commented, this is not
only due to the drug they contain, but also due to the formulation in which they are
offered. In this regard, formulations of sustained liberation provide a new factor that must
be considered, as they modify the liberation of the active ingredient, meaning serums may
be modified by a greater number of factors, including food or the concomitant
administration of other drugs, all of which could result in excessive fluctuations in the
levels of the drug in question.
As we have already expressed in this document, there are some important
limitations to bioequivalence studies. Contradictory studies regarding the bioequivalence
of some generic medicines in relation to the reference drug exist. This has led to the
recommendation not to substitute drugs that possess a narrow therapeutic index, or which
suffer a significant first-pass effect, or which need a frequent dosage adjustment (including
drugs with non-linear kinetic behaviour) (20, 21, 22, 23, 24, 25, 26, 27):
• Anticonvulsants
• Theophyllines
• Antiarrhythmics
305
For some drugs, substitution is not recommended without the authorisation of the
prescriber:
• Insulins
• Oral anticoagulants
• Haemostatic drugs for factors VIII and IX
• Cardiac glycosides and combinations
• Medicines subjected to special medical control (etretinate, acetohydroxamic acid,
clozapine)
There are reasonable doubts as to how to recommend not substituting many
medicines, including some noteworthy examples:
•
•
•
•
Non-steroidal anti-inflammatory medicines (NSAIMs): some drugs that contain
ibuprofen or piroxicam. In some cases due to the presence of enantiomers that
have non-linear kinetic behaviour, and in others due to the different solubility
observed between different samples.
Formulations of prolonged liberation for calcium antagonists, anticonvulsants or
NSAIMs.
Influence of the ingestion of foodstuffs in relation to changes in the absorption
of proton-pump inhibitors or verapamil.
Drugs that present a high hepatic extraction ratio (above 70%), due to the fact
the genetic polymorphism that controls the drug metabolism may determine
that some patients present a different metabolisation to what was expected.
An American agency, the Food and Drug Administration (FDA), has classified some
drugs as non-substitutable as they present potential or documented problems of
bioequivalence:
• Aminophylline, serum concentration
• Amitriptyline, serum concentration
• Cortisone acetate, injection
• Dexamethasone, serum concentration
• Dexamethasone acetate, injection
• Ethinyl estradiol, serum concentration
• Phytonadione, injection
• Levodopa, capsules, serum concentration
• Methylprednisolone acetate, injection
• Nortriptyline hydrochloride, capsules
306
• Promethazine, serum concentration
• Theophylline, capsules, serum concentration
• Oestrogen esters
• Conjugated oestrogens
In the words of Guillermo Tena, the president of the Asociación Española de
Sustancias y Especialidades Farmacéuticas Genéricas (Spanish Association for Generic
Pharmaceutical Specialities and Substances), prescription according to active ingredient is
not related to an increase in the use of generic pharmaceutical specialities, mainly due to
the fact that it aims for a markedly economic objective. Proof of this is the agreement
signed last year between the Servicio Andaluz de Salud (Andalusian Health Service) and the
Consejo Andaluz de Farmacéuticos (Andalusian Council of Pharmacists), in which
pharmacists promised to dispense the cheapest medicine when prescription is made
according to active ingredient. Said measure has not produced the desired results and the
Andalusian community has not managed to effectively implement generic pharmaceutical
specialities, proof of which is in the low quota of the generic drugs market in Andalusia,
which, in September of last year, amounted to 2.8%, more than half a point below the
national average.
The administration has to encourage the appropriate mechanisms so more generic
drugs are prescribed. Prescription cannot be limited to active ingredients as this does not
mean that the pharmacy will dispense a generic pharmaceutical speciality. If we have
various forms of prescribing a generic drug, we should not discard any as the saving is the
same, therefore a more generic active ingredient is prescribed or it is also prescribed with
the company name. The doctor must be given sufficient freedom to prescribe as he sees fit,
understanding the importance of prescribing a generic drug. A ruling that guides the doctor
to the cheapest medicine, even those that are found below the reference point, must not
be implemented in the computing programme available to primary care doctors, given that
this is only for financial reasons and not for the purpose of a prescription of quality. A
prescription of quality and better use of medicine must not be subjected exclusively to
financial criteria: a “copy” medicine cannot be considered a better option than a model
speciality or a generic drug merely because it is cheaper. The pharmacist for the health
district cannot be converted into an agent monitoring prescription from a single point of
view, that of pharmaceutical spending.
In view of the aforementioned, the possibility of the pharmacist, by virtue of the
previously cited agreement, being the person who decides what pharmaceutical speciality
is dispensed to the patient opens the door to financial incentives. This is a commercial
strategy that each company can carry out and which is only protected by its ethical
307
attitude. Previously, the Ministry of Health and Consumption sent a notice warning that
these incentives are illegal, but this is insufficient. It is important that this issue is
appropriately clarified as a regulated market must be transparent and indecisiveness
regarding certain points may favour or impede generic drugs as incentives constitute a
source of uncertainty that is difficult to resolve.
According to Tena, the Andalusian example is not great for generic drugs as, in this
community, prescription according to active ingredient stands at around 15%, of which at
least 12.2% corresponds to drugs for which a generic drug does not exist. Currently,
Andalusia has a quota of generic drugs of 2.8%, meaning it is still below the national
average. As such, the system of double reference prices is not efficient for the prescription
of generic drugs, nor is it effective in increasing saving. However, the Andalusian example is
clear in another aspect: only €4.5 million has been saved when the anticipated saving was
approximately €60 million.
308
Bibliography
1. Cabello, M.R., Tognoni, G., Lucena, M.I. ‘Farmacología clínica en atención primaria: un
desafío necesario’ [‘Clinical pharmacology in primary care: a necessary challenge’].
Medicina Clínica (Barcelona) 1996; 107: 299-304.
2. Baos, V. ‘La calidad en la prescripción de medicamentos’ [‘Quality in the prescribing of
medicines’]. Información Terapéutica del Sistema Nacional de Salud 1999, 23: 45-54.
3. Abadanes, J.C., Cabedo, V., Cunillera, R., García, J.J., Jolín, L., Martín, M., Prados, S.,
Vicens, C. ‘Factores que influyen en la prescripción farmacológica del médico de
atención primaria’ [‘Factors that influence the oharmacological orescription of the
orimary care doctor’]. Atención Primaria 1998; 22 (8): 391-98.
4. Puche, E., Saucedo, R., García, M., Bolaños, J., Villa, A. ‘Estudio del botiquín familiar y
algunas de sus características en la ciudad de Granada’ [‘Study of the family medicine
cabinet and some of its characteristics in the city of Granada’]. Medicina Clínica
(Barcelona) 1982; 79: 118-121.
5. Arias, A., Martín, M.L., Pardo, L. and Campillo, M. ‘Botiquines familiares y estructura
socio-sanitaria: estudio descriptivo de una muestra piloto’ [‘Family medicine cabinets
and the socio-health structure: descriptive study of a pilot sample’]. Atención Primaria
1986; 3: 128-132.
6. Caamaño, F., Figueiras, A., Lade, E., Gestal-Otero, J.J. ‘La automedicación: conceptos y
perfil de sus usuarios.’ [‘Self-medication: concepts and user profiles’] Gaceta Sanitaria
2000; 14: 294-299.
7. Hernández, B., Eiros, J.M. ‘Automedicación con antibióticos: una realidad vigente’ [‘Selfmedication with antibiotics: a current reality’]. Centro de salud 2001; 6: 357-64.
8. Baos, V. ‘Estrategias para reducir los riesgos de la automedicación’ [‘Strategies for
reducing the risks of self-medication’]. Información Terapéutica del Sistema Nacional de
Salud 2000; 24: 147-152
309
9. Laporte, J.R. ‘Automedicación: ¿la información de los usuarios aumenta al mismo tiempo
que el consumo?’ [‘Self-medication: Does user information increase parallel to
consumption?’] Medicina Clínica (Barcelona) 1997; 109: 795-796
10. Laporte, J.R., Carne, X., Vidal, X., Moreno, V., Juan, J. ‘Upper gastrointestinal bleeding in
relation to previous use of analgesics and non-steroidal anti-inflammatory drugs.’
Lancet 1991; 337: 8589
11. González, J., Orero, A., Rodríguez, M.L. ‘Uso de los antimicrobianos en la comunidad’
[‘Use of antimicrobials in the community’]. JANO 1997; 1206 (supplement): 4-8.
12. Orero, A., González, J., Prieto, J. ‘Antibióticos en los hogares españoles. Implicaciones
médicas y socioeconómicas’ [‘Antibiotics in Spanish homes. Medical and socioeconomic implications’]. Medicina Clínica (Barcelona) 1997; 109: 782-85
13. Orero, A., Ripoll, M.A., González, J. ‘Análisis de la automedicación con antibióticos en la
población española’ [‘Analysis of self-medication with antibiotics in the Spanish
population’]. Enferm. Infecc. Microbiol Clin. 1998; 16: 328-332
14. Barat, I., et al. ‘Drug therapy in the elderly: what doctors believe and patients actually
do.’ British Journal of Clinical Pharmacology 200; 51: 615-622
15. Barat, I., Andreasen, F., Damsgaard, E.M.S. ‘The consumption of drugs by 75-year-old
individuals living in their own homes.’ European Journal of Clinical Pharmacology 2000;
56:501-509
16. Anon. ‘Guidelines for the medical assessment of drugs for use in self-medication.’
World Health Organization (Regional Office for Europe). Copenhagen. 1986.
17. Rigueira, A.I. ‘Cumplimiento terapéutico. ¿Qué conocemos en España?’ [‘Treatment
adherence. What do we know in Spain?’]. Atención Primaria 2001; 27 (8): 559-68.
18. Márquez, E., Casado, J.J., Márquez, J.J. ‘Estrategias para mejorar el cumplimiento
terapéutico’ [‘Strategies for improving treatment adherence’] FMC 2001; 8 (8): 558-73.
310
19. Basterra, M. ‘El cumplimiento terapéutico’ [‘Treatment adherence’]. Revista
Pharmaceutical Care España 1999; 1: 97-106.
20. Bowers, A. ‘Regulatory considerations associated with the in vivo bioequivalence
assessment of metered-dose inhalers’. Drug Information Journal 1995; 29: 941-959.
21. Pidgen, A. ‘Bioequivalence and generic prescribing: an industrial view.’ Journal of
Pharmacy and Pharmacology 1996; 48: 11-16.
22. Meredith, P.A. ‘Generics drugs. Therapeutic equivalence.’ Drug Safety 1996; 15: 233242.
23. Mehvar, R., Jamali, F. ‘Bioequivalence of chiral drugs’. Clinical Pharmacokinetics 1997;
33: 122-141.
24. Patanik, R.N., Lesko, L.J., Chen, M.L., Williams, R.L. and the FDA individual equivalence
working group. ‘Individual bioequivalence: new concepts in the statistical assessment
of bioequivalence metrics.’ Clinical Pharmacokinetics 1997; 33: 1-6.
25. Abad, F., Martínez, E., Gálvez, M.A. ‘Estudios de bioequivalencia: análisis y aspectos
metodológicos’ [‘Bioequivalence studies: analysis and methodological aspects’]. In: El
ensayo clínico en España. A. García ed. Farmaindustria, Serie Científica. Madrid 2001:
69-80.
26. Frías, J., Guerra, P., Soto, A., Carcas, A. ‘Limitaciones de los estudios de bioequivalencia:
aspectos prácticos’ [‘Limitations of bioequivalence studies: practical aspects’]. In: El
ensayo clínico en España. A. García ed. Farmaindustria, Serie Científica. Madrid 2001:
81-92.
27. García, A., García, M. ‘Sustitución de medicamentos: equivalencias e inequivalencias’
[‘Substitution of medicines: equivalences and non-equivalences’]. In: El ensayo clínico
en España. A. García ed. Farmaindustria, Serie Científica. Madrid 2001: 93-118.
311
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Ethics in the Practise of
Acupuncture
313
SERIES OF SPECIAL DOCUMENTS FROM THE OMC
DOCUMENT XIII
THE ETHICS OF THE PRACTISE OF ACUPUNCTURE
Introduction
Acupuncture is a particularly popular practise in unconventional medical techniques.
Originating from China, it is currently used in at least 78 countries. In Belgium, 74% of
acupuncture treatments are administered by western doctors. In Germany, 77% of pain
clinics provide acupuncture. In the United Kingdom, 46% of western doctors recommend
an acupuncture treatment to their patients or treat their patients with acupuncture
themselves.
In many developed countries, the growing use of acupuncture indicates that other factors
that support it, apart from tradition and cost, exist. Concern over the adverse effects of
chemical drugs, the issues associated with viewpoints and stances of western medicine,
greater access of the public to health information, changes in values, and a reduced
tolerance to paternalism are some of these.
The World Health Organisation (WHO) has issued directives to help national health
authorities to establish regulations regarding the knowledge of acupuncture and the
experience required of doctors or other health professionals who wish to include
acupuncture in their professional practise, under the framework of modern western
medicine.
The European Court of Justice has passed rulings that state that in the absence of specific
regulations on complementary therapeutic techniques, the law to be followed will be
maintained within the limits of medical practise. The national health services in Germany,
France, Belgium, the United Kingdom and Switzerland reimburse the costs of acupuncture
treatment.
Reasons for the declaration
The use of acupuncture in modern medical care removes it from its traditional context
and applies it as a therapeutic technique for a limited number of illnesses or complaints,
for which it has a proven efficacy, without the need to reconcile the theories on which
modern medicine and traditional Chinese medicine are based.
In our country, the group of doctors who practise acupuncture is formed by physicians
who, in their usual practise, include acupuncture within the private system and the public
system, therefore increasing the possibilities of applying an appropriate therapy to the
patient’s pathology.
314
Medicine is a science and art such that – without prejudice to the obligation of the doctor
to provide conscientious and attentive updated care and the right of the patient to
receive safe care that has been verified by medical science – one of the unwavering rights
of the doctor is freedom to prescribe the best treatment for his patients. The doctor, in
exercising this freedom of prescription, answers to society, patients and professional
colleagues in accordance with the guidelines established in legal and deontological
regulations.
In recent years, a significant number of official medical associations have had a working
group (Sección Grupo de Trabajo) that gathers the doctors who practise acupuncture. The
associations must implement measures to check and guarantee a level of appropriate
training in these professionals such that this may be confirmed, given that no national
legislation exists.
For many years, acupuncture has been a common practise in our country: under the
protection of medical associations, academies of medicine and university master’s
courses are teaching this therapy without the existence of any official regulations or
control measures for its practise and teaching.
In light of the aforementioned, the Comisión Central de Deontología (Central Commission
for Deontology) will not judge the efficiency of acupuncture as a therapeutic technique:
the Organización Médica Colegial de España (Spanish Collegiate Medical Association, or
OMC) must regulate the particular deontological aspects of its practise. This activity has
been recognised and accepted by the WHO as a useful method in medical activity and it is
endorsed by continued practise across the centuries.
Concepts and definitions
Acupuncture is understood as the insertion of thin, solid, metal needles into the skin at
the corresponding points for the prevention or treatment of an illness, in addition to
including acupressure and electro-acupuncture, which is acupuncture with laser
moxibustion (local and focussed application of heat on acupuncture points using a
powdered and compressed combustible substance), and the application of suction pads,
which are therapeutic techniques related to traditional Chinese medicine.
Acupuncture is a therapeutic method that is based on the following principles:
•
Diagnostic principle: by applying medical theory to traditional Chinese medicine
with its specific terminology, a diagnosis can be reached for the application of a
therapeutic principle.
•
Therapeutic principle: by applying different therapeutic techniques, a series of
systems aimed at cure and re-balancing these techniques is launched.
315
•
Preventive principles: diagnosis in traditional Chinese medicine helps, through the
appropriate clinical analysis, to provide a series of preventive measures, dietary
recommendations, etc. for the purpose of preventing illness.
Of the three aforementioned principles, it can be deduced that acupuncture is a medical
practise that requires a diagnosis prior to the establishment of the therapeutic principle
that will mark the technique to be used, the prescription of points, the mode of
manipulation, or the techniques required to prevent illness in a specific patient.
As Law 44/2003, of 21 November, on the Health Professions states in article 6.2.a,
medical graduates are responsible for indicating and performing activities aimed at
promoting and maintaining health, preventing illnesses, and diagnosing the therapeutic
and rehabilitation treatment of patients as well as judging and providing a prognosis for
the processes that are the subject of attention.
In other words, if every lawful activity carried out by a legally qualified professional
doctor and aimed at curing an illness, alleviating symptoms, or promoting health is
understood as a medical act, therefore, diagnostic acts of cure, pain relief or health
preservation by direct or indirect means are included. We understand that the acts on
which the practise of acupuncture is based are medical and therefore reserved as such,
regardless of whether another health professional is authorised to apply the prescriptions
of the doctor who practise acupuncture.
It is obvious that the public and private legal assets at play require the control of a
practise and the regulation of training by the State, bearing in mind the criteria of the
Consejo General de Colegios Oficiales de Médicos (General Council of Official Medical
Colleges, or CGCOM).
Deontological and professional aspects
A doctor who practises acupuncture is subjected to all the guidelines indicated in the
Code of Ethics and Medical Deontology (CEMD).
Given the unique nature of this therapeutic technique and current teaching systems, it is
necessary to explain and determine some particular aspects that require special
attention.
The CEMD of 1999 states, in article 21.2, the obligation of the doctor who practises
acupuncture to inform patients as to the need to continue with essential treatment, if
applicable.
316
Likewise, he must keep his knowledge of the action methods of acupuncture up to date as
they are discovered in order to integrate them with those of conventional western
medicine (article 18 of the CEMD).
The doctor will not use any techniques from traditional Chinese medicine in which he is
not sufficiently trained.
The patient who subjects himself to this type of treatment must be sure that he is being
treated by an expert in this technique from a precise, diagnostic perspective. He must
also be guaranteed that the person who will be applying these techniques understands
them and has been subjected to the same control required for conventional medical
practise.
When a patient requires another clear therapeutic instruction, this should be
communicated to him and he should be referred to the corresponding specialist.
Providing false hope, prolonging a treatment without justification or indicating the
renunciation of other treatments that are useful to the patient are ethically reprehensible
actions.
Before beginning a treatment, the doctor must obtain the informed consent of the
patient, preferably in writing. Specifically, he must clearly inform the patient of the
unique nature of the technique or techniques that will be employed, the number of
sessions anticipated, the anticipated benefits and the probable development. He must
also mention the adverse effects that arise according to the characteristics of the patient
himself and the possibility of the treatment exacerbating a symptom before proceeding
with treatment.
Bearing in mind the greater good of the patient, a doctor who practises acupuncture must
always cooperate as far as possible with the primary care doctor or specialist who usually
attends to the health of the patient. It may occur that some patients do not wish for their
family doctor to know that they are being treated with unconventional medical
techniques; the patient’s wish for confidentiality must be respected although it is prudent
to encourage him to communicate this information to his family doctor, given that
acupuncture treatment may reduce or change the need for medicines.
The publicity of a doctor who practises acupuncture will be governed by general
deontological regulations. It must be a prudent and truthful and without comparison to
other health professionals, especially considering that acupuncture is currently the
subject of intense unqualified practise that uses fraudulent publicity.
317
Conclusions
Acupuncture, as has been defined previously, is an invasive therapeutic technique that
requires a prior diagnosis, preferably in writing, according to the hypotheses of traditional
Chinese medicine in which it may only be performed by a doctor who, with a complete
view of western medicine, considers it to be the most appropriate or best complementary
treatment for a specific patient.
Following the proposals of the WHO, it is the responsibility of the national government to
regulate the practise and teaching of acupuncture, with the prior counselling of the OMC.
318

Declarations of the Comisión central de deontología

Transcription

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